Observational Cam DiSP July 02

01-July 2018
2nd
Drug Safety Punjab EDITION
Monthly Newsletter
In this Edition:
Section-A:
Global Drug Safety
• DSA-154 Daclizumab Beta Section-B: • DSA-118 Bandage Elasto
Immediate Suspension: Craft Cotton Crepe
TGRP Highlights
Risk Of Serious Bandage Has Been
Inflammatory Brain Declared SUB-
Disorders • DSA-162 Heparin Related STANDARD
• DSA-155 Hypertensive Crisis • DSA-119 Tablet Dologin
Dipeptidylpeptidase-4 Has Been Declared SUB-
Inhibitors: Potential Risk Section-C: STANDARD
Of A Skin Reaction OOS reports & Recalls • DSA-120 Suspension
(Bullous Pemphigoid) Fevernil-C Has Been
• DSA-156 Efavirenz Risk Declared SUB-
Of Prolonged QT. • DSA-100 Injection Carasil STANDARD
• DSA-157 Iohexol And Has Been Declared SUB- • DSA-122 Suppository
Imeprol Risk Of Acute STANDARD Utenol Has Been Declared
Generalized • DSA-110 Tablet Convidol SUB-STANDARD
Exanthematous Pustulosis C&F Has Been Declared • DSA-123 Injection
• DSA-158 Radium-223 SUB-STANDARD Colimoxin Has Been
Dichloride Not To Be Used • DSA-111 Suspension Ibo- Declared SUB-
Together With Z Has Been Declared STANDARD
Prednisone/Prednisolone SUB-STANDARD • DSA-124 Injection
• DSA-159 Clozapine Risk • DSA-112 Tablet Calpol Colimoxin Has Been
Of Agranulocytosis Has Been Declared SUB- Declared SUB-
• DSA-160 Sodium-glucose STANDARD STANDARD
Cotransporter-2 (SGLT2) • DSA-113 Augmentin DS • DSA-125 Syrup
Inhibitors: Potential Risk (Powder For Amoxicillin Has Been
Of A Rare Brain Condition Reconstitution) Has Been Declared SUB-
(Posterior Reversible Declared SUB- STANDARD
Encephalopathy STANDARD • DSA-126 Tablet Cardace
Syndrome) In Patients • DSA-114 Injection Omezol Has Been Declared SUB-
Who Developed Diabetic Has Been Declared SUB- STANDARD
Ketoacidosis STANDARD • DSA-128 Inhalation
• DSA-161 Oral Over-The- • DSA-116 Tablet Rithmo Solution Zaftolin Has Been
Counter Benzocaine (Film Coated) Has Been Declared SUB-
Products: Drug Safety Declared SUB- STANDARD
Communication - Risk Of STANDARD • DSA-129 Tablet Neocobal
Serious And Potentially • DSA-117 Tablet Rithmo Has Been Declared SUB-
Fatal Blood Disorder (Film Coated) Has Been STANDARD
Declared SUB-
STANDARD
Provincial Pharmacovigilance Centre

Provincial Drug Control Unit Government of the Punjab, Primary Contact: 04299206203
& Secondary Healthcare Department Email: pdcu.pshealth@gmail.com 1
Office: 48/1 Kacha Lawrence Road, Lahore,
/PDCU.Punjab @PDCU_Punjab /PDCU.Punjab
Pakistan.
• DSA-130 Injection Nitid • DSA-140 Injection Aqpine • DSA-150 Injection
Has Been Declared SUB- Has Been Declared SUB- Tyloprim-S Has Been
STANDARD STANDARD Declared SUB-
• DSA-131 Suspension • DSA-144 Suspension STANDARD
Levoplus Has Been Levoplus Has Been • DSA-151 Injection
Declared SUB- Declared SUB- Metrocol Has Been
STANDARD STANDARD Declared SUB-
• DSA-132 Suspension • DSA-145 Suspension STANDARD
Levoplus Has Been Levoplus Has Been • DSA-152 Tablet Platagg-I
Declared SUB- Declared SUB- Has Been Declared SUB-
STANDARD STANDARD STANDARD
• DSA-135 Suspension • DSA-146 Suspension • DSA-153 Gauze Swab
Levoplus Has Been Levoplus Has Been Steriband Has Been
Declared SUB- Declared SUB- Declared SUB-
STANDARD STANDARD STANDARD
• DSA-136 Suspension • DSA-147 Suspension
Levoplus Has Been Levoplus Has Been
Declared SUB- Declared SUB- Section-D:
STANDARD STANDARD DRAP Highlights
• DSA-137 Suspension • DSA-148 Bandage
Levoplus Has Been Elastocraft Cotton Crepe
Bandage Has Been • DSA-163 Cancellation Of
Declared SUB-
Declared SUB- LICENSE And
STANDARD
STANDARD REGISTRATION Of M/S
• DSA-138 Suspension
• DSA-149 Syrup Neolac Spadix Pharmaceutical
Levoplus Has Been
Has Been Declared SUB- Islamabad
Declared SUB-
STANDARD STANDARD
Section-A: Global Drug Safety
DSA-154 Daclizumab Beta: Immediate Suspension of Medicine

Market Authorization & Recall: Risk Of Serious Inflammatory Brain
Disorders
meningoencephalitis in was restricted to patients who

BACKGROUND:
patients with multiple have tried at least two other
The European Medicines
sclerosis. Three of the cases disease-modifying treatments
Agency (EMA) has
were fatal. [1] and cannot be treated with
recommended the immediate
other multiple sclerosis
suspension of medicine PROBLEM: treatments. Also, the
market authorization and Daclizumab beta is indicated available evidence indicate
recall of Daclizumab Beta for treating relapsing forms of that immune reactions
following 12 reports of multiple sclerosis. Following observed in the reported
serious inflammatory brain a 2017 review of the cases may be linked to the
disorders worldwide, medicine’s effects on the use of Daclizumab Beta.
including encephalitis and liver, the use of the medicine
/PDCU.Punjab @PDCU_Punjab /PDCU.Punjab Office: 48/1 Kacha Lawrence Road, Lahore
RECOMMENDATION: patients currently being Daclizumab Beta has already
To protect patients’ Health, treated with daclizumab beta voluntarily requested a
EMA has recommended the stop treatment, and consider withdrawal of the medicine’s
immediate suspension of the alternatives. Patients marketing authorization and
medicine’s marketing stopping treatment must be informed EMA of its intention
authorization in the EU and a followed up for at least six to stop clinical studies.
recall of batches from months. EMA’s
pharmacies and hospitals. recommendation to suspend REFERENCE:
EMA advises that no new Daclizumab Beta and recall 1. European Medication
patient should start treatment the product is being sent to Agency (EMA)
with Daclizumab Beta. the European Commission (www.ema.europa.eu)
Healthcare professionals for a legally binding decision. 2. http://www.who.int/medici
should immediately contact The company that markets nes WHO
pharmaceuticals
newsletter: 2018, No. 2
A Advice to Healthcare Professionals and

Consumers:
All Healthcare Professionals and Consumers are advised to immediately stop
the use of Daclizumab Beta. Further, physicians are advised to keep
monitoring the patients for up to 6 months after discontinuation of the
Daclizumab Beta.
DSA-155 Dipeptidylpeptidase-4 Inhibitors (Alogliptin, Saxagliptin,

Sitagliptin & Linagliptin): Potential Risk Of A Skin Reaction (Bullous
Pemphigoid)
BACKGROUND: All 24 reports were RECOMMENDATION:

DPP-4 inhibitors, known as considered to show a Health Canada has
gliptins are prescription possible link between the requested that the product
medicines indicated for type- skin reaction and the drug. Of information for
2 diabetes in adults. the 24 reports, three deaths dipeptidylpeptidase-4 (DPP-
were reported, one of which 4) inhibitors is updated to
PROBLEM: was considered to be include the risk of bullous
A total of 24 serious possibly linked to bullous pemphigoid.
international reports of pemphigoid from using the
potential bullous pemphigoid DPP-4 inhibitor. Health REFERENCE:
with the use of Alogliptin (16) Canada’s review concluded Summary Safety Review,
and Saxagliptin (8) were that there may be a link Health Canada, (www.hc-
identified by manufacturers between any of the DPP-4 sc.gc.ca)
and from a search in the inhibitors and the risk of
Canada vigilance database. bullous pemphigoid.
A Advice to Healthcare Professionals
and Consumers:
All Healthcare Professionals and Consumers are advised to keep alert for skin
reactions associated with the use of dipeptidylpeptidase-4 inhibitors and
encourage patients to report such reactions.
DSA-156 Efavirenz: Risk Of Prolonged QT
BACKGROUND: Several cases of prolonged revised to include the risk of

Efavirenz is indicated for HIV- QT have also been reported prolonged QT as a
1 infection. in patients treated with precaution.[1]
Efavirenz overseas.
PROBLEM: REFERENCE:
Prolonged QT interval was RECOMMENDATION:
observed in conjunction with Ministry of Health Labour and 1. Revision of Precautions,
increased blood Welfare (MHLW) and MHLW/PMDA
concentrations of Efavirenz in Pharmaceutical & Medical (www.pmda.go.jp/english/
an overseas clinical study Devices Agency (PMDA) )
investigating the effect of this Japan have concluded that 2. http://www.who.int/medici
drug on the QT interval. package insert for Efavirenz nes WHO
should be pharmaceuticals
A
Advice to Healthcare Professionals:
All Healthcare Professionals and Consumers are advised to keep monitoring
prolongation of QT interval while prescribing Efavirenz.
DSA-157 Iohexol and Imeprol: Risk Of Acute Generalized
Exanthematous Pustulosis
BACKGROUND: the last three fiscal years in revision of the package insert
Iohexol and Imeprol are Japan. A causal relationship for Iohexol and Imeprol to
indicated for various with the products could not include the risk of Acute
angiography and x-ray be excluded for those Generalized Exanthematous
procedures. patients. No fatal cases have Pustulosis as a clinically
been reported. significant adverse reaction.
PROBLEM:
Two cases of Acute RECOMMENDATION: REFERENCE:
Generalized Exanthematous Ministry of Health Labour and Revision of Precautions,
Pustulosis were reported in Welfare (MHLW) and MHLW/PMDA
patients who used Imeprol in Pharmaceutical & Medical (www.pmda.go.jp/english/)
Devices Agency (PMDA)
Japan have requested the
A Advice to Healthcare Professionals:

All Healthcare Professionals and Consumers are advised to keep monitoring of
adverse drug reactions while carrying out radiological procedure involving use
of Iohexol and Imeprol.
DSA-158 Radium-223 dichloride Not to be used together with

Abiraterone and Prednisone/Prednisolone
BACKGROUND: PROBLEM: have died, compared with

Radium-223 is used to treat EMA’s Product Risk 28.2% of patients given
prostate cancer in adult men. Assessment Committee placebo
It is authorized for use when (PRAC) has reviewed prednisone/prednisolone. [1]
medical or surgical castration preliminary data from an
does not work, and when the ongoing clinical study in RECOMMENDATION:
cancer has spread to the metastatic prostate cancer EMA recommends that
bones and is causing patients. In this study 34.7% Radium-223 dichloride
symptoms such as pain but is of patients treated with should not be used in
not known to have spread to radium-223, combination with Abiraterone
other internal organs. prednisone/prednisolone & Prednisone/Prednisolone
due to an increased risk of the benefits and risks of REFERENCE:
death & fracture of bones. Radium-223 is complete. The 1. EMA, 9 March 2018
The restriction in use is a EMA will communicate (www.ema.europa.eu)
temporary measure until the further once the review has 2.http://www.who.int/medicin
ongoing in-depth review of been completed. es WHO pharmaceuticals
All Healthcare Professionals are advised to avoid the concomitant use of

Radium-223 dichloride with Abiraterone and Prednisone/Prednisolone.
DSA-159 Clozapine: Risk Of Agranulocytosis
BACKGROUND: effective. Health Canada RECOMMENDATION:

Clozapine is indicated to treat reviewed all of the available Health Canada has
symptoms of schizophrenia in evidence related to the requested that manufacturers
adults when other drugs have effectiveness of the white of clozapine submit a report,
not helped. Agranulocytosis blood cell monitoring in two years, of all data
is a known adverse drug measures currently in place collected in relation to
reaction that can occur in for clozapine. agranulocytosis with use of
association with clozapine Health Canada has received clozapine.
use. For this reason, white 92 Canadian reports of low
blood cell levels are numbers of white blood cells REFERENCE:
monitored periodically in in patients using Clozapine. A Summary Safety Review,
patients treated with review of these reports found Health Canada, (www.hc-
clozapine to make sure that that 11 of them were possibly sc.gc.ca) (See WHO
they do not become too low. linked to clozapine use. The Pharmaceuticals Newsletters
review concluded that No.5, 2015: Modifications for
PROBLEM: monitoring measures that are monitoring neutropenia in the
During routine safety review in place to detect low United)
activities, concerns were numbers of white blood cells
raised about whether or not are acceptable, however this
processes to monitor risk should still be monitored.
agranulocytosis were
All Healthcare Professionals and Consumers are advised to keep monitoring

patients for agranulocytosis taking Clozapine.
DSA-160 Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors:

Potential Risk Of A Rare Brain Condition: Posterior Reversible
Encephalopathy Syndrome (PRES) In Patients Who Developed
Diabetic Ketoacidosis (DKA)
BACKGROUND: cotransporter 2 (SGLT2) use of these health products.

SGLT2 inhibitors lower blood inhibitors and developed Health Canada will continue
sugar in adults with type 2 diabetic ketoacidosis.[1] to monitor the safety of
diabetes. At the time of the Both reports involved SGLT2 inhibitors.
review, Health Canada had Canagliflozin and suggested revised to include the risk of
received two unique that PRES could possibly be prolonged QT as a
Canadian reports of PRES in associated with the medicine. precaution.
patients treated with SGLT2 However, other risk factors
inhibitors who had developed such as DKA and severe REFERENCE:
DKA. infection could have played a
role in the events. 1. Summary Safety Review,
PROBLEM: Health Canada, 8
Health Canada has reviewed RECOMMENDATION: February 2018 (www.hc-
the potential risk of posterior Health Canada encourages sc.gc.ca)
reversible encephalopathy consumers and healthcare 2. http://www.who.int/medici
syndrome (PRES) in patients professionals to report any nes WHO
treated with sodium-glucose adverse effects related to the pharmaceuticals
All Healthcare Professionals are advised to keep caution for development of

Posterior Reversible Encephalopathy Syndrome (PRES) in patients taking
Sodium-Glucose Cotransport-2 (SGLT2) inhibitors. .
DSA-161 Oral Over-The-Counter Benzocaine Products: Drug Safety
Communication - Risk Of Serious And Potentially Fatal Blood
Disorder
BACKGROUND: in adults and children 2 years • Revising the directions to

Benzocaine is a local and older if they contain direct parents and caregivers
anesthetic contained in some certain warnings on the drug not to use the product in
OTC products for the label. Due to the infants and children younger
temporary relief of pain due significant safety risk of than 2 years.
to minor irritation, soreness, Methemoglobinemia, we FDA continue to monitor the
or injury of the mouth and have urged manufacturers safety and effectiveness of
throat. that they should stop OTC benzocaine products
marketing OTC oral drug and intend to take additional
PROBLEM: products for treating teething actions in the future as
Benzocaine, a local in infants and children needed. FDA will notify the
anesthetic, can cause a younger than 2 years. If public about any updates. In
condition in which the amount companies do not comply, addition to recent actions
of oxygen carried through the FDA will take action to regarding OTC benzocaine
blood is greatly reduced. This remove these products from products, we are also
condition, called the market. requiring a standardized
methemoglobinemia, can be FDA has also urged Methemoglobinemia warning
life-threatening and result in manufacturers of OTC oral to be included in the
death. [1] drug products containing prescribing information of all
benzocaine for adults and prescription local anesthetics.
RECOMMENDATION: children 2 years and older to
The FDA is warning that make the following changes REFERENCE:
over-the-counter (OTC) oral to the labels of their products: 1.
drug products containing • Adding a warning about https://www.fda.gov/Safety/M
benzocaine should not be Methemoglobinemia; edWatch/SafetyInformation/S
used to treat infants and • Adding contraindications, afetyAlertsforHumanMedical
children younger than 2 FDA’s strongest warnings, Products/ucm608612.htm
years. FDA is also warning directing parents and 2.
that benzocaine oral drug caregivers not to use the http://www.who.int/medicines
products should only be used product for teething and not WHO pharmaceuticals
to use in infants and children newsletter: 2018, No. 2
younger than 2 years; and
A Advice to Healthcare Professionals and

Pharma Industry :
All Healthcare Professionals and Consumers are advised to avoid the use of
Benzocaine (Local Anesthetic) containing products in infants and children
younger than 2 years. Pharmaceutical Manufacturers of Benzocaine products
should update Labels and Package Inserts immediately.
Section-B: TGRP Highlights
DSA-162 Heparin Related Hypertensive Crisis
SUMMARY: patient condition. It is not encountered. According to

Provincial Drug Control Unit clear whether patient VigiAccess, 256 cases of
received a case report of develops symptom upon Heparin related Hypertension
Heparin related Hypertensive reinstitution of therapy or not. had been reported. [2] In co-
Crisis. The drug is an morbid medical condition,
Anticoagulant and have BACKGROUND: Sinus Bradycardia cannot be
Hypertension as an TGRP 282, is a report by related with reported event.
uncommon side effect. [1] CPPO DHQ Sheikhupura, Concomitant use of other
patient presented with Sinus medication (Suxamethonium)
AUDIENCE: Bradycardia. Previously a could also be related with
Health Care Professionals, known patient of presenting complaint.
Pharmacist and Consumers. Hypertension. He developed
Hypertensive Crisis after REFERENCES:
FINDINGS: being administered Heparin
TGRP 282, reported event prescribed by attending 1. LEXICOMP
Hypertensive Crisis is physician. 2. VigiAccess
reasonably associated with
drug administration time. PROBLEM:
Discontinuation of suspected Patient received with Sinus
drug result in recovery of Bradycardia however, after
administration of Heparin,
Hypertensive Crisis
A
Advice to Healthcare Professionals:
It is advised to clinicians to keep caution in prescribing this medicine to
patients, also closely monitor therapy and ask patients to inform promptly if
such symptoms develop. If further such reactions are observed, report through
mss.punjab.gov.pk/reporttgrp.
Section-C: OOS Reports & Recalls
DSA-100 Injection Carasil Has Been Declared SPURIOUS
INJECTION: Rawal Town, Islamabad and RECOMMENDATION:

Carasil 100ml sent it to the Punjab Drug This product does not meet
(Butaphosphan, Testing Laboratory appropriate quality standards
Cyanocobalamin, Taurine, (DTL) for testing and and specifications. This
Nicotinamide, DL- analysis. product will fail to produce
Methionine) PROBLEM: desired therapeutic effect. All
BATCH NO.: W9405 Manufacture has claimed DL- concerned are intimated to
MANUFACTURED BY: Methionine 18.7mg/ml, but keep avoid in procurement ,
Dae Sung Micro Biologicals Drug Testing Laboratory storage, dispensation,
Labs, Seoul, Korea Punjab did not identify the promotion, sale and use of
BACKGROUND: DL- Methionine. Therefore, this batch of pharmaceutical
Provincial Drug Inspector DTL has declared it product.
collected the sample from SPURIOUS.
DSA-110 Tablet Convidol C&F Has Been Declared SUB-

STANDARD
PRODUCT NAME: PROBLEM: RECOMMENDATION:

Convidol C&F (Paracetamol: This product failed to comply This product does not meet
500mg, Caffeine:65mg, the Friability, Assay and appropriate quality standards
Chlorpheniramine Maleate: Disintegration. Weight loss and specifications. This
2mg) (1.33%) does not comply the product may fail to produce
BATCH NO.: 226 Friability specifications. desired therapeutic effect. All
MANUFACTURED BY: Three out of six units failed to concerned are intimated to
Convell Laboratories, Saidu, comply the disintegration test keep avoid in procurement,
Sharif, Sawat, Pakistan in specified time. dispensation, promotion, sale
BACKGROUND: Manufacturer has claimed and use of this batch of
Provincial Drug Inspector Caffeine 65mg, but DTL pharmaceutical product.
collected the sample from determined 22.035mg
Hassan Abdal and sent it to (33.90%). Therefore, DTL
the Punjab Drug Testing has declared it SUB-
Laboratory(DTL) for testing STANDARD.
and analysis.
DSA-111 Suspension IBO-Z Has Been Declared SUB-STANDARD

IBO-Z (Ibuprofen 100mg/5ml) Manufacturer has claimed the This product does not meet
BATCH NO.: L-997 quantity of Ibuprofen appropriate quality standards
MANUFACTURED BY: 100mg/5ml, but Drug Testing and specifications. This
Z-JANS, 148-A Industrial Laboratory has determined product may produce sub-
Estate, Hayatabad, 70.74mg/5ml (70.74%), therapeutic effect. All
Peshawar, Pakistan which is out of specifications. concerned are intimated to
BACKGROUND: Therefore, DTL has declared keep avoid in procurement,
Provincial Drug Inspector it SUB-STANDARD. dispensation, promotion, sale
collected the sample from and use of this batch of
Talagang and sent it to the pharmaceutical product.
Punjab Drug Testing
Laboratory (DTL) for testing
and analysis.
DSA-120 Tablet CALPOL Has Been Declared SUB-STANDARD

Calpol (Paracetamol: 500mg) This product does not comply This product does not meet
BATCH NO.: GCDNZ the acceptance criteria for appropriate quality standards
MANUFACTURED BY: Friability. Average weight and specifications. This
GLAXOSMITHKLINE, F/268, loss determined is 1.15%. product may break during
S.I.T.E Karachi, Pakistan Therefore, DTL has declared transport and handling. All
BACKGROUND: it SUB-STANDARD. concerned are intimated to
Provincial Drug Inspector keep avoid in procurement,
collected the sample from dispensation, promotion, sale
Sub- Medical Store Depot, and use of this batch of
Sunder Estate, Lahore and pharmaceutical product.
sent it to the Punjab Drug
Testing Laboratory(DTL) for
testing and analysis.
DSA-113 Augmentin DS (Powder For Reconstitution) Has Been
Declared SUB-STANDARD

Augmentin DS (Co- Manufacturer has claimed the This product does not meet
Amoxiclav 312.50mg/5ml) quantity of active ingredient appropriate quality standards
BATCH NO.: GARLL CLAVULANIC ACID and specifications. This
MANUFACTURED BY: 62.5mg/5ml, but Drug Testing product may fail to produce
GLAXOSMITHKLINE, F/268, Laboratory determined desired therapeutic effects.
S.I.T.E Karachi, Pakistan 40.25mg/5ml (64.4%). All concerned are intimated
BACKGROUND: Therefore, DTL has declared to keep avoid in procurement,
Provincial Drug Inspector it SUB-STANDARD. dispensation, promotion, sale
collected the sample from and use of this batch of
Sub- Medical Store Depot, pharmaceutical product.
Sunder Estate, Lahore and
sent it to the Punjab Drug
Testing Laboratory (DTL) for
DSA-114 Injection Omezol Has Been Declared SUB-STANDARD

Omezol (Omeprazole 40mg) Manufacturer has claimed This product does not meet
BATCH NO.: OM18020 Omeprazole 40mg/vial but appropriate quality standards
MANUFACTURED BY: vial to vial assay varies and specifications. This
Bosch Pharmaceuticals 35.04mg, 35.04mg, 40.0mg, product may show variation
(PVT) LTD,221 Sector 23, 41.3mg (87.6%, 87.6%, in therapeutic effect. All
Korangi Industrial Area, 90.0% and 103.2%) concerned are intimated to
Karachi respectively. The assay of keep avoid in procurement,
BACKGROUND: vials does not comply with dispensation, promotion, sale
Provincial Drug Inspector manufacturer specifications. and use of this batch of
collected the sample from Therefore, DTL has declared pharmaceutical product.
Children Hospital, Lahore it SUB-STANDARD.
and sent it to the Punjab Drug
DSA-116 Tablet Rithmo (Film Coated) Has Been Declared SUB-
STANDARD

Rithmo (Clarithromycin The product failed to comply This product does not meet
500mg) with the Dissolution test. The appropriate quality standards
BATCH NO.: 001D Drug Testing Laboratory and specifications. This
MANUFACTURED BY: (DTL) has determined that product may not produce
M/S SAMI Pharma, F-95, the product results are out of desired bioavailability and
S.I.T.E Karachi USP specifications as may fail to produce desired
BACKGROUND: claimed by Manufacturer. therapeutic effect. All
Provincial Drug Inspector Therefore, DTL has declared concerned are intimated to
collected the sample from it SUB-STANDARD. keep avoid in procurement,
Benazir Bhutto Hospital dispensation, promotion, sale
Rawalpindi and sent it to the and use of this batch of
Punjab Drug Testing pharmaceutical product.
Laboratory(DTL) for testing
and analysis.
DSA-117 Tablet Rithmo (Film Coated) Has Been Declared SUB-

STANDARD

Rithmo (Clarithromycin The product failed to comply This product does not meet
500mg) with the Dissolution test. The appropriate quality standards
BATCH NO.: 019C Drug Testing Laboratory and specifications. This
MANUFACTURED BY: (DTL) has determined that product may not produce
M/S SAMI Pharma, F-95, the dissolution results are out desired bioavailability and
S.I.T.E Karachi of USP specifications as may fail to produce desired
BACKGROUND: claimed by manufacturer. therapeutic effect. All
Provincial Drug Inspector Therefore, DTL has declared concerned are intimated to
collected the sample from it SUB-STANDARD. keep avoid in procurement,
Holy Family Hospital dispensation, promotion, sale
Rawalpindi and sent it to the and use of this batch of
Punjab Drug Testing pharmaceutical product.
Laboratory(DTL) for testing
and analysis.
DSA-118 Bandage Elasto Craft Cotton Crepe Bandage Has Been

Bandages: Elasto Craft Manufacturer has claimed This product does not meet
Cotton Crepe Bandage (Size WARPS NTL 17.1/cm and appropriate quality standards
7.5cm × 4.5M) WEIGHT NLT 149g/m2. The and specifications. All
BATCH NO.: 04B18 DTL has determined WARPS concerned are intimated to
MANUFACTURED BY: 15.9776/cm and WEIGHT keep avoid in procurement,
Cotton Craft (Pvt.) Ltd. 133.5516g/m2 respectively, dispensation, promotion, sale
Sundar Industrial Estate, which failed to comply with and use of this batch of
Raiwind Road, Lahore the stated specifications of pharmaceutical product.
BACKGROUND: the product (BPC 2017).
Provincial Drug Inspector Therefore, DTL has declared
collected the sample from it SUB-STANDARD.
Rawalpindi Institute of
Cardiology and sent it to
Drug Testing Laboratory
(DTL) for testing and
analysis.
DSA-119 Tablet Dologin Has Been Declared SUB-STANDARD

Dologin (Mefenamic Acid: The product fails to comply This product does not meet
250mg) with the disintegration test. appropriate quality standards
BATCH NO.: 348 The DTL determined that at and specifications. This
MANUFACTURED BY: stage 1; 4 out of 6 units fail to product may fail to produce
Opal Laboratories(Pvt.) Ltd, comply and at stage 2, 10 out desired therapeutic effect. All
LC-41, L.I.T.E, Landhi, of 18 units are out of the concerned are intimated to
Karachi stated specifications. keep avoid in procurement,
BACKGROUND: Therefore, DTL has declared dispensation, promotion, sale
Provincial Drug Inspector it SUB-STANDARD. and use of this batch of
collected the sample from pharmaceutical product.
Jhelum and sent it to Drug
DSA-120 Suspension Fevernil-C Has Been Declared SUB-
STANDARD

Fevernil-C (Paracetamol: The manufacturer has This product does not meet
120mg/5ml, claimed Chlorpheniramine appropriate quality standards
Chlorpheniramine Maleate: Maleate 1mg/5ml, but the and specifications. This
1mg/5ml) DTL determined 5.97mg/5ml product may produce toxicity
BATCH NO.: 6651 (597%). Therefore, DTL has of Chlorpheniramine maleate
MANUFACTURED BY: declared it SUB-STANDARD. and potentially may be fatal
Meditech Pharmaceuticals, to patients. All concerned are
15-D Industrial Estate, intimated to keep avoid in
Hayatabad, Peshawar procurement, dispensation,
BACKGROUND: promotion, sale and use of
Provincial Drug Inspector this batch of pharmaceutical
collected the sample from product.
Dina and sent it to Drug
DSA-122 Suppository Utenol Has Been Declared SUB-STANDARD
PRODUCT NAME: Drug Testing Laboratory RECOMMENDATION:

Utenol (Intrauterine (DTL) for testing and This product does not meet
Pessaries or Vaginal analysis. appropriate quality standards
Pessaries) and specifications. This
(Sulphathiazole 1750mg, PROBLEM: product may potentially be
Penicillin G 100000 IU, Manufacturer has claimed harmful to patients. All
Streptomycin Sulphate 50mg, Streptomycin 50mg/unit and concerned are intimated to
Ethinylestradiol 0.5mg) Penicillin G 63.19 mg/unit, keep avoid in procurement,
BATCH NO.: VD033 but DTL has determined, dispensation, promotion, sale
MANUFACTURED BY: Streptomycin 76.61mg/unit and use of this batch of
Star Laboratories Limited, (153.23%) and Penicillin G pharmaceutical product.
Multan Road, Lahore. 13.38mg/unit (21.17%) which
Pakistan are out of stated
BACKGROUND: specifications. Therefore,
Provincial Drug Inspector DTL has declared it SUB-
collected the sample from STANDARD.
Rawal Town and sent it to
DSA-123 Injection Colimoxin Has Been Declared SUB-STANDARD

Colimoxin 100ml (Amoxicillin Manufacturer has claimed the This product does not meet
100mg/ml, Colistine 250000 amount of Colistin 250000 appropriate quality standards
IU/ml) IU/ml but DTL determined and specifications. Colimoxin
BATCH NO.: CM-212 428925 IU/ml (171.57%) is a veterinary product and
MANUFACTURED BY: which is out of stated may potentially be harmful to
Selmore Pharma, Multan specifications. Therefore, animals. All concerned are
Road, Lahore DTL has declared it SUB- intimated to keep avoid in
BACKGROUND: STANDARD. procurement, dispensation,
Provincial Drug Inspector promotion, sale and use of
collected the sample from this batch of pharmaceutical
Rawal Town and sent it to product.
analysis.
DSA-124 Injection Colimoxin Has Been Declared SUB-STANDARD

Colimoxin 100ml (Amoxicillin Manufacturer has claimed This product does not meet
100mg/ml, Colistine 250000 Colistin 250000 IU/ml, but appropriate quality standards
IU/ml) DTL determined 430525 and specifications. Colimoxin
BATCH NO.: CM-214 IU/ml (172.21%) which does is a veterinary product and
MANUFACTURED BY: not comply to stated may potentially be harmful to
Selmore Pharma, Multan specifications. Therefore, animals. All concerned are
Road, Lahore DTL has declared it SUB- intimated to keep avoid in
BACKGROUND: STANDARD. procurement, dispensation,
Provincial Drug Inspector promotion, sale and use of
collected the sample from this batch of pharmaceutical
Rawal Town and sent it to product.
analysis.
DSA-125 Syrup Amoxicillin Has Been Declared SUB-STANDARD

Amoxicillin 125mg/5ml Manufacturer has claimed the This product does not meet
(Amoxycillin as Trihydrate) amount of Amoxycillin appropriate quality standards
BATCH NO.: 16E007 Trihydrate 125mg/5ml but and specifications. This
MANUFACTURED BY: DTL determined product may fail to produce
Medimarkers Laboratories 88.15mg/5ml (70.52%) which the desired therapeutic effect.
(Pvt) Ltd, Hyderabad. does not comply to stated All concerned are intimated
Pakistan specifications. Therefore, to keep avoid in procurement,
BACKGROUND: DTL has declared it SUB- dispensation, promotion, sale
Provincial Drug Inspector STANDARD. and use of this batch of
Chakwal and sent it to Drug
DSA-126 Tablet Cardace Has Been Declared SUB-STANDARD

Cardace 5mg Analyst found eight tablets This product does not meet
(Enalapril 5mg) with rough surface and five appropriate quality standards
BATCH NO.: 80 tablets with erased logo. and specifications. This
MANUFACTURED BY: Tablet powder observed product may break before
ZAFA Pharmaceuticals outside the tablet pocket administration. All concerned
Laboratories (Pvt) Ltd showing improper sealing. are intimated to keep avoid in
Industrial Area, Karachi, The product also failed to procurement, dispensation,
Pakistan comply with the friability test promotion, sale and use of
BACKGROUND: (2.33% loss) which is higher this batch of pharmaceutical
Provincial Drug Inspector than stated in USP (NMT product.
collected the sample from 1%). Therefore, DTL has
DHQ Hospital Rawalpindi declared it SUB-STANDARD.
and sent it to Drug Testing
and analysis.
DSA-128 Inhalation Solution Zaftolin Has Been Declared SUB-
STANDARD

Zaftolin 0.5%w/v The product failed to comply This product does not meet
(Salbutamol 5mg/ml) the physical test. The product appropriate quality standards
BATCH NO.: 73 was found in white colored and specifications. This
MANUFACTURED BY: plastic bottle instead of product may be harmful for
ZAFA Pharmaceuticals amber glass bottle with shrink the patient. All concerned are
Laboratories (Pvt) Ltd wrap printed with ZAFA. The intimated to keep avoid in
Industrial Area, Karachi, DTL determined the product procurement, dispensation,
Pakistan bottle was not as per stated promotion, sale and use of
BACKGROUND: specifications. Therefore, this batch of pharmaceutical
Provincial Drug Inspector DTL has declared it SUB- product.
collected the sample from STANDARD.
Holy Family Hospital
Rawalpindi and sent it to
analysis.
DSA-129 Tablet Neocobal Has Been Declared SUB-STANDARD

Film Coated Neocobal The stated amount of This product does not meet
(Mecobalamin 0.5mg) Mecobalamin is 0.5mg/tablet appropriate quality standards
BATCH NO.: 3116 but DTL determined and specifications. All
MANUFACTURED BY: 1.0mg/tablet (199.77%), this concerned are intimated to
Pulse Pharmaceuticals (Pvt) way failed to comply with keep avoid in procurement,
Ltd, Raiwind Road, Lahore specifications. Therefore, dispensation, promotion, sale
BACKGROUND: DTL has declared it SUB- and use of this batch of
Provincial Drug Inspector STANDARD. pharmaceutical product.
collected the sample from
Murree and sent it to Drug
DSA-130 Injection Nitid Has Been Declared SUB-STANDARD

Nitid 50mg/2ml Manufacturer claims This product does not meet
(Ranitidine 50mg) Ranitidine 50mg/2ml but DTL appropriate quality standards
BATCH NO.: 086 determined 56.23mg/2ml and specifications. All
MANUFACTURED BY: (112.45%) which does not concerned are intimated to
Danas Pharmaceuticals (Pvt) comply stated specifications keep avoid in procurement,
Ltd, Kahuta Road, Islamabad (90%-110%). Therefore, DTL dispensation, promotion, sale
BACKGROUND: has declared it SUB- and use of this batch of
Provincial Drug Inspector STANDARD. pharmaceutical product.
Hazro and sent it to Drug
DSA-131 Suspension Levoplus Has Been Declared SUB-

STANDARD

LEVOPLUS (Oxyclozanide: The manufacturer has This product does not meet
3.0g/100ml, Levamisole HCL: claimed Oxyclozanide appropriate quality standards
1.5gm/100ml) 3.0gm/100ml but DTL has and specifications. This
BATCH NO.: L-2170 determined Oxyclozanide product may produce sub-
MANUFACTURED BY: 2.3728gm/100ml (79.093%) therapeutic effect. All
Attabak Pharmaceuticals which is out of stated concerned are intimated to
Industries, 5C. I-10/3, specifications (92.5%- keep avoid in procurement,
Industrial Area Islamabad 107.5%). Therefore, DTL has dispensation, promotion, sale
BACKGROUND: declared it SUB-STANDARD. and use of this batch of
Provincial Drug Inspector pharmaceutical product.
analysis.
STANDARD

1.5gm/100ml) 3.0g/100ml but DTL has and specifications. This
Attabak Pharmaceuticals which is out of stated concerned are intimated to
Industries, 5C. I-10/3, specifications (92.5%- keep avoid in procurement,
Industrial Area Islamabad 107.5%). Therefore, DTL has dispensation, promotion, sale
BACKGROUND: declared it SUB-STANDARD. and use of this batch of
Provincial drug inspector . pharmaceutical product.
analysis.

STANDARD

1.5gm/100ml) 3.0g/100ml and Levamisole and specifications. This
BATCH NO.: L-2175 1.5gm/100mlbut Drug Testing product may produce toxic
MANUFACTURED BY: Laboratory (DTL) has effects. All concerned are
Attabak Pharmaceuticals determined Oxyclozanide intimated to keep avoid in
Industries, 5C. I-10/3, 3.723gm/100ml (124.099%) procurement, dispensation,
Industrial Area Islamabad and Levamisole promotion, sale and use of
BACKGROUND: 1.722gm/100ml (114.832%) this batch of pharmaceutical
Provincial drug inspector which is out of stated product.
collected the sample from specifications (92.5%-
Rawal Town and sent it to 107.5%). Therefore, DTL has
Drug Testing Laboratory declared it SUB-STANDARD.
analysis.
STANDARD

1.5gm/100ml) 3.0g/100ml but DTL has and specifications. All
BATCH NO.: L-2184 determined Oxyclozanide concerned are intimated to
MANUFACTURED BY: 2.19gm/100ml (73.10%) keep avoid in procurement,
Attabak Pharmaceuticals which is out of mentioned dispensation, promotion, sale
Industries, 5C. I-10/3, specifications. Therefore, and use of this batch of
Industrial Area Islamabad DTL has declared it SUB- pharmaceutical product.
BACKGROUND: STANDARD.
Provincial drug inspector
analysis.

STANDARD

BATCH NO.: L-2185 1.5gm/100ml but DTL has product may produce sub-
MANUFACTURED BY: determined Oxyclozanide therapeutic effect. All
Attabak Pharmaceuticals 1.86gm/100ml (62.02%) and concerned are intimated to
Industries, 5C. I-10/3, Levamisole 1.36gm/100ml keep avoid in procurement,
Industrial Area Islamabad (90.57%) which is out of dispensation, promotion, sale
BACKGROUND: claimed specifications. and use of this batch of
Provincial drug inspector Therefore, DTL has declared pharmaceutical product.
analysis.
STANDARD

Attabak Pharmaceuticals which is out of claimed concerned are intimated to
Industries, 5C. I-10/3, specifications. Therefore, keep avoid in procurement,
Industrial Area Islamabad DTL has declared it SUB- dispensation, promotion, sale
BACKGROUND: STANDARD. and use of this batch of
Provincial drug inspector pharmaceutical product.
analysis.

STANDARD

3.0g/100ml, Levamisole HCL: claimed Levamisole HCL appropriate quality standards
1.5gm/100ml) 1.5gm/100ml but DTL has and specifications. All
BATCH NO.: L-2164 determined Levamisole concerned are intimated to
MANUFACTURED BY: 1.6774gm/100ml (111.83%) keep avoid in procurement,
Attabak Pharmaceuticals which is out of claimed dispensation, promotion, sale
Industries, 5C. I-10/3, specifications. Therefore, and use of this batch of
Industrial Area Islamabad DTL has declared it SUB- pharmaceutical product.
BACKGROUND: STANDARD.
Provincial drug inspector
analysis.
DSA-140 Injection Aqpine Has Been Declared SUB-STANDARD

Aqpine 1gm (Cefepime) The manufacturer has This product does not meet
BATCH NO.: 057 claimed Cefepime 1g/vial but appropriate quality standards
MANUFACTURED BY: DTL has determined and specifications. This
Shawan Pharmaceuticals, 0.8704g/vial (87.04%) which product may produce sub-
Rawat, Rawalpindi, Pakistan is out of claimed therapeutic effects. All
BACKGROUND: specifications. Therefore, concerned are intimated to
Provincial drug inspector DTL has declared it SUB- keep avoid in procurement,
collected the sample from STANDARD. dispensation, promotion, sale
Taxila and sent it to Drug and use of this batch of
Testing Laboratory (DTL) for pharmaceutical product.

STANDARD

BATCH NO.: L-2050 1.5gm/100ml but DTL has product may not produce
MANUFACTURED BY: determined Oxyclozanide desired therapeutic effect. All
Attabak Pharmaceuticals 2.1672gm/100ml (72.24%) concerned are intimated to
Industries, 5C. I-10/3, and Levamisole keep avoid in procurement,
Industrial Area Islamabad 1.388gm/100ml (92.59%) dispensation, promotion, sale
BACKGROUND: which is out of specifications. and use of this batch of
Provincial drug inspector Therefore, DTL has declared pharmaceutical product.
analysis.
STANDARD

MANUFACTURED BY: 2.2152gm/100ml (73.84%) therapeutic effects. All
Attabak Pharmaceuticals which is out of specifications. concerned are intimated to
Industries, 5C. I-10/3, Therefore, DTL has declared keep avoid in procurement,
Industrial Area Islamabad it SUB-STANDARD. dispensation, promotion, sale
BACKGROUND: and use of this batch of
analysis.

STANDARD

1.5gm/100ml) 3.0gm/100ml but DTL has and specifications. This
Attabak Pharmaceuticals which is out of specifications. concerned are intimated to
Industries, 5C. I-10/3, Therefore, DTL has declared keep avoid in procurement,
Industrial Area Islamabad it SUB-STANDARD. dispensation, promotion, sale
BACKGROUND: and use of this batch of
analysis.
STANDARD

BATCH NO.: L-2181 1.5gm/100ml but DTL has product may fail to produce
MANUFACTURED BY: determined Oxyclozanide desired therapeutic effect. All
Attabak Pharmaceuticals 1.7703gm/100ml (59.01%) concerned are intimated to
Industries, 5C. I-10/3, and Levamisole keep avoid in procurement,
Industrial Area Islamabad 1.3231gm/100ml (88.21%) dispensation, promotion, sale
BACKGROUND: which are out of and use of this batch of
Provincial drug inspector specifications. Therefore, pharmaceutical product.
collected the sample from DTL has declared it SUB-
Rawal Town and sent it to STANDARD.
analysis.
DSA-148 Bandage Elastocraft Cotton Crepe Bandage Has Been


ELASROCRAFT Cotton Manufacturer claimed This product does not meet
Crepe Bandage WARPS Average not less appropriate quality standards
(Cotton Crepe Bandage Size than 17/cm and WEIGHT not and specifications. All
7.5cm × 4.5M) less than 140g/m2. The DTL concerned are intimated to
BATCH NO.: 23C18 has determined WARPS keep avoid in procurement,
MANUFACTURED BY: Average 13.6/cm and dispensation, promotion, sale
Cotton Craft (Pvt) Ltd. Plot WEIGHT 131.9g/m2 and use of this batch of
No 407,408 Sundar Industrial respectively which failed to pharmaceutical product.
Estate, Raiwind Road, comply with the stated
Lahore. Pakistan specifications of the product
BACKGROUND: (BPC). Therefore, DTL has
Provincial Drug Inspector declared it SUB-STANDARD.
MSD Sundar Industrial Estate
and analysis.
DSA-149 Syrup Neolac Has Been Declared SUB-STANDARD

Syrup NEOLAC 120ml The manufacturer has This product does not meet
(Lactulose 67gm/100ml) claimed Lactulose appropriate quality standards
BATCH NO.: 404 67gm/100ml but Drug Testing and specifications. This
MANUFACTURED BY: Laboratory (DTL) has product may fail to produce
NEOMEDIX Plot No 5, N/5, determined Lactulose desired therapeutic effect. All
National Industrial Zone, 46.52g/100ml (69.44%), concerned are intimated to
Rawat, Islamabad which is out of specifications. keep avoid in procurement,
BACKGROUND: Therefore, DTL has declared dispensation, promotion, sale
Provincial Drug Inspector it SUB-STANDARD. and use of this batch of
Murree and sent it to Drug
DSA-150 Injection Tyloprim-S Has Been Declared SUB-STANDARD

Injection TOLYPRIM-S 100ml The manufacturer has This product does not meet
(Tylosin Tartrate: 5g, claimed Tylosin 5g/100ml but appropriate quality standards
Sulphamethoxypyridazine:15 DTL has determined Tylosin and specifications. This
g, Trimethoprim:3g) 3.7085g/100ml (74.17%) product may fail to produce
BATCH NO.: INJ-3865 which is out of specifications desired therapeutic effects.
MANUFACTURED BY: (90%-125%). Therefore, DTL All concerned are intimated
Leads Pharma (Pvt) Ltd, Plot has declared it SUB- to keep avoid in procurement,
No 81-A Street No 6, I-10/3, STANDARD. dispensation, promotion, sale
Industrial Area, Islamabad and use of this batch of
BACKGROUND: pharmaceutical product.
Provincial Drug Inspector
analysis.
DSA-151 Injection Metrocol Has Been Declared SUB-STANDARD

Injection METROCOL 100ml The manufacturer has This product does not meet
(Tylosin Tartrate: 50mg/ml, claimed Colistin 10mg/ml but appropriate quality standards
Colistin Sulphate:10mg/ml, DTL has determined and specifications. This
Dimetridazole: 100mg/ml) 20.89mg/ml (208.89%) which product may produce toxic
BATCH NO.: INJ-3866 is out of specifications (90%- effects. All concerned are
MANUFACTURED BY: 125%). Therefore, DTL has intimated to keep avoid in
Leads Pharma (Pvt) Ltd, Plot declared it SUB-STANDARD. procurement, dispensation,
No 81-A Street No 6, I-10/3, promotion, sale and use of
Industrial Area, Islamabad this batch of pharmaceutical
BACKGROUND: product.
Provincial Drug Inspector
analysis.
DSA-152 Tablet Platagg-I Has Been Declared SUB-STANDARD

Film Coated Tablet The manufactured claimed This product does not meet
PLATAGG-I Round Film Coated Tablets, appropriate quality standards
(Clopidogrel: 75mg) with an inscription of “Z” on and specifications. All
BATCH NO.: 90 one side and “75” on the concerned are intimated to
MANUFACTURED BY: other. On analysis the results keep avoid in procurement,
ZAFA Pharmaceutical showed rough surface and dispensation, promotion, sale
Laboratories (Pvt) Ltd, L-1/B, chipped edges, also and use of this batch of
Block-22 Federal B Industrial imprinting was not clear due pharmaceutical product.
Area, Karachi, Pakistan to picking in many tablets.
BACKGROUND: Therefore, DTL has declared
Provincial Drug Inspector it SUB-STANDARD.
DHQ Hospital Rawalpindi
and analysis.
DSA-153 Gauze Swab Steriband Has Been Declared SUB-
STANDARD

Gauze Swab STERIBAND The product failed to comply This product does not meet
[Gauze Swab: 10cm × 10cm physical description and appropriate quality standards
(8 PLY)] sterility test. The DTL has and specifications. This
BATCH NO.: 1263 determined that the product product may potentially be
MANUFACTURED BY: does not comply with the harmful to patient All
M/S Faisal Pharmaceutical BPC specifications for concerned are intimated to
Industries, 602-B, S.I.E, Absorbent Cotton Gauze and keep avoid in procurement,
Sargodha Road, Faisalabad also contain weaving defects dispensation, promotion, sale
BACKGROUND: and cut edges were not fast. and use of this batch of
Provincial Drug Inspector Therefore, DTL has declared pharmaceutical product.
Rawalpindi Institute of
Cardiology and sent it to
analysis.
Section-D: DRAP Highlights
DSA-163 Cancellation Of Manufacturing LICENSE And

REGISTRATION Of Products M/S Spadix Pharmaceuticals
Islamabad
BACKGROUND: of Drug Manufacturing 1005(I)/2017 on 14-12-2017

Central Licensing Board License Invalid / Surrended / for their following products
(CLB) in its 255th meeting Cancelled by Central named as:
dated 16-17 June 2017, Licensing Board, Registration Zodex Injection, Dexime
cancelled Manufacturing of drugs also become invalid Capsules, Nodex Injection,
License of M/S Spadix and thus cancellation letters Dexpime Injection 1g, Dexef
Pharmaceuticals. shall be issued accordingly. Capsules, Dexef Dry
Subsequent to the CLB Suspension, Dexime
decision, Registration Board EXPLANATION: Suspension, Dexime
in its 276th meeting dated 22- The firm applied for Suspension.
25 November 2017 decided regularization of renewal of
that as a result of declaration Registration under SRO
Registration Board in its letter was issued to the firm storage, sale and use of any
278th Meeting held on 29-31 on 30th March 2018 by of the products of Spadix
January, 2018, rejected the Registration Section. Pharmaceuticals until
case for renewal and restoration of Manufacturing
Registration of all products of RECOMMENDATION: License and Registration of
Spadix Pharmaceuticals All concerned are intimated Spadix Products by DRAP.
have also been cancelled. to keep avoid in procurement,
Cancellation of Registration dispensation, promotion,

Observational Cam DiSP July 02

Diunggah oleh

Informasi Dokumen

Hak Cipta

Format Tersedia

Bagikan dokumen Ini

Bagikan atau Tanam Dokumen

Opsi Berbagi

Apakah menurut Anda dokumen ini bermanfaat?

Apakah konten ini tidak pantas?

Hak Cipta:

Format Tersedia

Observational Cam DiSP July 02

Diunggah oleh

Hak Cipta:

Format Tersedia

01-July 2018

Provincial Pharmacovigilance Centre

Section-A: Global Drug Safety

DSA-154 Daclizumab Beta: Immediate Suspension of Medicine

meningoencephalitis in was restricted to patients who

A Advice to Healthcare Professionals and

DSA-155 Dipeptidylpeptidase-4 Inhibitors (Alogliptin, Saxagliptin,

BACKGROUND: All 24 reports were RECOMMENDATION:

DSA-156 Efavirenz: Risk Of Prolonged QT

BACKGROUND: Several cases of prolonged revised to include the risk of

A Advice to Healthcare Professionals:

DSA-158 Radium-223 dichloride Not to be used together with

BACKGROUND: PROBLEM: have died, compared with

A Advice to Healthcare Professionals:

All Healthcare Professionals are advised to avoid the concomitant use of

DSA-159 Clozapine: Risk Of Agranulocytosis

BACKGROUND: effective. Health Canada RECOMMENDATION:

All Healthcare Professionals and Consumers are advised to keep monitoring

DSA-160 Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors:

BACKGROUND: cotransporter 2 (SGLT2) use of these health products.

A Advice to Healthcare Professionals:

All Healthcare Professionals are advised to keep caution for development of

BACKGROUND: in adults and children 2 years • Revising the directions to

A Advice to Healthcare Professionals and

DSA-162 Heparin Related Hypertensive Crisis

SUMMARY: patient condition. It is not encountered. According to

DSA-100 Injection Carasil Has Been Declared SPURIOUS

INJECTION: Rawal Town, Islamabad and RECOMMENDATION:

DSA-110 Tablet Convidol C&F Has Been Declared SUB-

PRODUCT NAME: PROBLEM: RECOMMENDATION:

PRODUCT NAME: PROBLEM: RECOMMENDATION:

DSA-120 Tablet CALPOL Has Been Declared SUB-STANDARD

PRODUCT NAME: PROBLEM: RECOMMENDATION:

PRODUCT NAME: PROBLEM: RECOMMENDATION:

DSA-114 Injection Omezol Has Been Declared SUB-STANDARD

PRODUCT NAME: PROBLEM: RECOMMENDATION:

PRODUCT NAME: PROBLEM: RECOMMENDATION:

DSA-117 Tablet Rithmo (Film Coated) Has Been Declared SUB-

PRODUCT NAME: PROBLEM: RECOMMENDATION:

PRODUCT NAME: PROBLEM: RECOMMENDATION:

DSA-119 Tablet Dologin Has Been Declared SUB-STANDARD

PRODUCT NAME: PROBLEM: RECOMMENDATION:

PRODUCT NAME: PROBLEM: RECOMMENDATION:

DSA-122 Suppository Utenol Has Been Declared SUB-STANDARD

PRODUCT NAME: Drug Testing Laboratory RECOMMENDATION:

PRODUCT NAME: PROBLEM: RECOMMENDATION:

DSA-124 Injection Colimoxin Has Been Declared SUB-STANDARD

PRODUCT NAME: PROBLEM: RECOMMENDATION:

PRODUCT NAME: PROBLEM: RECOMMENDATION:

DSA-126 Tablet Cardace Has Been Declared SUB-STANDARD

PRODUCT NAME: PROBLEM: RECOMMENDATION:

PRODUCT NAME: PROBLEM: RECOMMENDATION:

DSA-129 Tablet Neocobal Has Been Declared SUB-STANDARD

PRODUCT NAME: PROBLEM: RECOMMENDATION:

PRODUCT NAME: PROBLEM: RECOMMENDATION:

DSA-131 Suspension Levoplus Has Been Declared SUB-

PRODUCT NAME: PROBLEM: RECOMMENDATION:

PRODUCT NAME: PROBLEM: RECOMMENDATION:

DSA-134 Suspension Levoplus Has Been Declared SUB-

PRODUCT NAME: PROBLEM: RECOMMENDATION:

PRODUCT NAME: PROBLEM: RECOMMENDATION:

DSA-136 Suspension Levoplus Has Been Declared SUB-

PRODUCT NAME: PROBLEM: RECOMMENDATION:

PRODUCT NAME: PROBLEM: RECOMMENDATION: