Recall – Drug Regulatory Authority of Pakistan

Recall Alert: Voluntary Recall of 36 Batches of Motival Tablets (Reg # 004539) Manufactured by M/s GSK Pakistan Limited, Karachi.

Muhammad Ayub Naveed Recall Alerts February 18, 2025February 19, 2025Recall

Recall Alert

DRAP Alert No	N^oI/S/02-25-18
Action Date	18^th February 2025.
Target Audience	– National Regulatory Field Force. – Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	The firm M/s GSK Pakistan Limited, Karachi has notified Drug Regulatory Authority of Pakistan that they have initiated voluntary recall of 36 batches of Motival Tablets due to the detection of nitrosamine impurity, N-nitroso nortriptyline. Moreover, the firm has reported that it has ceased the manufacture and release of Motival Tablets. The details of the recalled product lots are as follows:

Therapeutic Goods (s) Affected: –

Product Names	Composition	Batch Details	Manufactured by
Motival Tablets 5 × 20’s (Reg # 004539)	Nortiptyline as HCl 10mg + Fluphenazine HCl 0.5mg	Batch No. 9P8L, A95S, A95Y, AN5N, AN5P, AN5R, AN5T, CK7G, CK7H, DT7B, DT7D, DL8J, DT7C, H58X, H58Y, H59A, J77W, J77V, K36F, K36E, KD6N, KD6P, M32F, ME8N, ME8R, R47H, R47K, R47L, SA7F, SA7G, SA6V, WM8R, WM8T, WM8U, YB7A, YB7B.	M/s. GSK Pakistan Limited, Plot # 5, Sector 21, Korangi Industrial Area, Karachi.

Risk Statement:	The risk of nitrosamine impurity in nortriptyline, like other pharmaceutical products, is a broader concern that has become more prominent after several incidents. These impurities are believed to have carcinogenic potential in certain situations.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

Rapid Alert: CRACKDOWN AGAINST FALSIFIED/SPURIOUS DRUGS

Muhammad Ayub Naveed Uncategorized February 17, 2025February 19, 2025Recall

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Rapid Alert

DRAP Alert No	N^oI/S/02-25-18
Action Date	17th February, 2025
Target Audience	1· National Regulatory Field Force of DRAP and Provincial Drug Control Departments 2· Healthcare Professionals (Physicians, Pharmacists & Nurses) 3. General Public
Problem Statement	Drug Testing Laboratory, Sindh has informed to Drug Regulatory Authority of Pakistan that samples of following products taken by various provincial drug inspectors, have been declared ‘*Spurious*’ (falsified). Moreover, the following firms and their associated products were found to be fictitious. The details of the reports are as below:

The product identification details are as under:

Therapeutic goods affected:

Product	Batch No*	Mfg Date	Exp. Date	Manufacturer Name (as per label)	Remarks
Evosef 250mg capsule (Cephradine 250mg)	HF-001			Purported to be manufactured by East Pharmaceutical 19-Km Sheikhupura road, Lahore	Spurious. Cephradine not identified
Mirzpan Suspension 100mg/5ml (Cefixime)	0008			M/s Miraz Pharma, Plot No: 23 Kasur Industries, Kasur.	Spurious, Cefixime not identified
Mirzolam Tablet 0.5mg (Alprazolam)	0007			M/s Miraz Pharma, Plot No: 23 Kasur Industries, Kasur.	Spurious, Alprazolam not identified
Bromalax Tablet 3mg (Bromazepam)	B-01			M/s Brom Pharmaceuticals (Pharmaceutical Industries), 21-Km Ferozpur Road, Lahore.	Spurious, Bromazepam not identified
Malixime Suspension 200mg/5ml (Cefixime)	78011			M/s Menakline Pharma, S Site Plot 11, Korangi Industrial Area, Karachi.	Spurious, Cefixime not identified
Lexopam Tablet 3mg (Bromazepam)	B-01			M/s Porm Pharmaceuticals (Pharmaceutical Industries), 220 Industrial Estate Hayatabad, Peshawar.	Spurious, Bromazepam not identified
Zionex Tablet 0.5mg (Alprazolam)	0032			M/s Multicare Pharmaceutical, Plot # 23, Korangi Industrial Area, Karachi.	Spurious, Alprazolam not identified
Tramaking-225 Mega tablet 225mg (Tramadol HCl)	TRD2002			Name of Manufacturer not mentioned.	Spurious
Alcoxime Suspension 100mg/5ml (Cefixime)	A2011			M/s Alpine Laboratories (Pvt.) Ltd: Plot# A-41, S.I.T.E Indsutrial Area, Sector 3 North Karachi Super Highway 75500-Pakistan.	Spurious, Cefixime not identified

Risk Statement:	Falsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences.
Action Initiated	The Regulatory field force has been directed to conduct surveillance activities throughout the supply chain to confiscate the counterfeit product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such product should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of this product from the circulation.
Advice for Healthcare Professionals	All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) are advised to increase surveillance in the market to ensure the effective removal of this products. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available at this link.
Advice for Consumer	Consumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the same to DRAP through Adverse Event Reporting Form or online through this link.

Consultative Workshop on Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods

Asad Ullah Events July 21, 2023July 26, 2023DRAP, Inspectors, Patient Safety, QualityDefects, RapidAlert, Recall

National Regulatory Authorities are responsible to ensure that recalls are handled properly and promptly, including alerting the public, classifying the type of drug recall, and safely removing the affected product from the market. DRAP in collaboration with WHO, organized one-day consultative workshop on “Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods” held at DRAP Headquarter in Islamabad on 20th July, 2023. The workshop was aimed at ensuring strong communication skills and knowledge to effectively handle the SF threat and execution of recalls and rapid alerts. Government Analysts from all Quality Control Laboratories (QCLs) working under the DRAP Act 2012 and Drug Act 1976, as well and representatives from drug control administration of all federating units participated in the workshop.

The workshop focused on the following key objectives:

Implementation of effective and integrated Recall and Rapid Alert system in Pakistan.
Emphasizing the need and importance of Recall and Rapid Alert System.
Training and building capacity of all the participants.
Enhancing coordination and communication with provincial governments and related departments.
Safe disposal system of SF products
Improvement in DRAP’s guidelines and harmonization with International best practices.

**Risk Communication flow chart for handling SF threats**

Core Activities and Topics Covered

1. Introduction and Objectives of Workshop The day began with an overview of current system for rapid alerts and recalls for removing defective therapeutic goods from the market. Director Quality Assurance and Lab Testing, DRAP briefed the participants on the strategies designed to strengthen the collaboration among regulators and QCLs of all federating units. He emphasized the importance of timely and accurate communication to combat the challenge of SF therapeutic goods.

2. Overview of DRAP’s guidelines on Recalls and Rapid Alerts of Defective products This session explained the guidelines of DRAP and action response currently opted by DRAP, highlighting its strengths and limitations. Participants engaged in group discussions to evaluate which methods would be most effective in different scenarios.

3. WHO recommendation on Recalls and Rapid Alerts System in the benchmarking visit Participants were introduced to the WHO GBT indicators, sub-indicators and IDPs, WHO recent visit and their recommendation for the improvement of the current Rapid Alert system. The trainer comprehensively delivered the details, ensuring that the information provided is easily comprehensible and actionable.

4. Harmonization of Terminologies for Defective Products and Role of QCLs in Detection and Disposal of SF products This segment focused on the terminologies being used nationally and their harmonization with WHO recommended terminologies. Later the role of Quality Control Laboratories was emphasized and discussed in group discussion.

5. Best practices for storage and disposal of SF products This session highlighted the current available practices and international practices as recommended by the WHO for safe storage and disposing of the SF products.

6.Effective communication among stakeholders for their removal from the market ;Recall is an effective means of protecting the public from a defective or potentially harmful product, and strong communication among relevant stakeholders is essential for the effective recall of SF Products. It was suggested to utilized modern communication channels by all federating units to ensure in time action on trigger information to safeguard public health. It was agreed by all the participants that prompt and effective communication is very crucial for implementing an proficient Rapid Alert and Recall System to removal of SF product from markets.

7. Practical Exercises The afternoon session involved hands-on practical exercises. Participants were divided into groups and tasked with case studies for different hypothetical scenarios. Case studies and simulations illustrated the effective collaboration between all the relevant stakeholders. This interactive exercise encouraged teamwork and allowed attendees to apply the concepts learned throughout the day.

8. Concluding Remarks and Distribution of Certificates Director Pharmaceutical Evaluation & Registration (PE&R) concluded the workshop with his closing remarks on appreciating the active participation from all regulatory entities and QCLs across Pakistan. The certificates of participation were distributed among the participants at the end of session.

Recall Alert: Drug Product; Spadix Injection (Batch# 570) by M/s. Tabros Pharma Karachi

Asad Ullah Recall Alerts April 20, 2023April 20, 2023DRAP, Patient Safety, QA & LT, QualityDefects, Recall

Recall Alert

DRAP Alert No	N^oI/S/20-23-21
Action Date	20^th April 2023
Target Audience	1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions 3. General Public
Product(s) Affected	Spadix 4mL Injection Composition: Phloroglucinol and Trimethylphloroglucinol Manufactured by: M/s. Tabros Pharma, (Pvt) Ltd., Karachi Batch No. 570
Problem / Issue	A video is circulating on social media regarding presence of a fly/insect in a liquid injection ampoule visible with naked eye, apparently seems to be having adulterated quality. The matter is still under investigation, however as a precautionary measure, to prevent any public health hazard, the alleged drug is being recalled from market.
Risk Statement	Drug Product contains fly/insect is of adulterated quality which may compromise the standard quality of drugs as not being sterile. The sterility is a basic quality attribute of all Injectable drugs. In this case such adulterated drug may initiate but not limited to following reaction in patients/users (i) Anaphylactic shock in patients which may lead to death of patient (ii) Skin rashes, itching, difficulty in breathing (iii) Sub optimal to no therapeutic effect for indicated medical treatment.
Action Initiated	-The manufacturing company / registration holder has been directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk. -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company. -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product. -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.

Recall-of-Spadix-Injectin Download

Recall Alert: Drug Product; Hydralazine 25mg Tablets (Batch # 257) by M/s Zafa Pharmaceuticals (Pvt) Ltd, Karachi .

Asad Ullah Recall Alerts February 23, 2023February 23, 2023Alert, Recall

Recall Alert

DRAP Alert No	N^oI/S/02-23-12
Action Date	21^st February 2023.
Target Audience	1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions 3. General Public
Product(s) Affected	Hydralazine 25mg Tablets Active Ingredient(s): Hydralazine Company: M/s. Zafa Pharmaceuticals (Pvt) Ltd, Karachi. Batch No. 257 Manufacturing Date: 10-2022 Expiry Date: 10-2027
Problem / Issue	CDL Karachi has declared the batch No. 257 of Hydralazine 25mg Tablets, manufactured by M/s. Zafa Pharmaceuticals (Pvt) Ltd, Karachi. as substandard drug product.
Action Initiated	-The manufacturing company has been directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk. -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company. -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product. -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.

Hydralazine-25mg-Tab-Zafa-Recall-Alert Download

Rapid Alert: Urgent Recall of Suspected Products for Contamination of DEG / EG

Asad Ullah Product Recalls, Recall Alerts, Safety Info February 21, 2023February 22, 2023Alert, DRAP, HOTC, Pharnacovigilance, QA & LT, QualityDefects, RapidAlert, Recall

Rapid Alert

Urgent Recall of Suspected Product for contamination of DEG / EG

DRAP Alert No	N^oI/S/02-23-8
Action Date	20^th February 2023
Target Audience	1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions 4. General Public
Problem Statement	Medical Control Agency, Gambia has issued a Safety Alert Ref: – MCA/AD/23/MJK(029) dated 13th February,2023 for KOF Relief Syrup bearing Batch# L394, manufactured by M/s Davis Pharmaceutical Laboratories, Islamabad-Pakistan due to presence of Ethylene Glycol (EG) at unacceptable levels. DRAP Inspectorate has initiated the investigation based on this information, and decided to recall all the suspected products manufactured by the firm using the same source of excipient i.e Glycerin and Propylene Glycol (PG). The details of suspected contaminated products are as under: –

Therapeutic Goods Affected:-

Sr	Product Name	Composition	Batch #	Manufactured by (as stated on label)
1	Bromgen Syp 100mL (Reg. Export Only)	Bromhexine HCl	L392	M/s Davis Pharmaceutical Laboratories, Islamabad-Pakistan
2	Kof Relief Syp 100mL (Reg, Export Only)	Chlorpheniramine Maleate Ammonium Chloride Sodium Citrate Menthol Green Banana Flavour	L394	-do-
3	Macofen Syp 100mL (Reg, Export Only)	Ibuprofen	L395	-do-
4	Vomitil Suspension 120mL (Reg, Export Only)	Domperidone	L400, L408, L414,	-do-
5	Asperfin Syp 60mL	Ketotifen	L401	-do
6	Davis Tonic Syrup (250mL, 120ml)	Vitamin B12 Vitamin B1 HCl Vitamin B2 Vitamin B6 Vitamin B3 Folic Acid Vitamin B5 Sodium Glycerophosphate Manganese Sulphate Ferric Ammonium Citrate	CS07, CS20, CS21, CS23, CS30, CS31, CS42, CS70, CS71, CS159	-do-
7	Zinc Syp 60mL	Zinc Sulphate Monohydrate	CS06, CS36, CS37, CS38, CS39, CS45, CS46, CS47, CS48, CS60, CS75, CS76, CS80, CS81, CS83, CS92, CS93	-do-

Action Initiated	The manufacturing company has been directed to immediately recall the suspected batches of these products from the market. All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying these batches of products. The remaining stock should be quarantine and return to the supplier / company. Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned products. -Adverse reactions or quality problems experienced with the use of these product shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should STOP using these products and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, and report the incident to Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. -All therapeutic goods must be obtained from the licensed pharmacies, and other authorized / licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

Davis-Rapid-Alert-of-Suspected-Contaminated-Products Download