Product Recalls

Recall Alert: Drug Product; Fentos 50mg Tablets (Batch # 599) By M/s. Hisun Pharmaceutical Industries, Gadoon-Pakistan

Asad Ullah Recall Alerts October 6, 2022November 29, 2022

Recall Alert

DRAP Alert No	NoII/S/09-22-21
Action Date	6th October, 2022
Target Audience	1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions 3. General Public
Product(s) Affected	Fentos 50mg Tablets, Active Ingredient(s): Diclofenac Potassium Company: M/s. Hisum Pharmaceutical Insutries Gadoon, Pakistan Batch No. 599 Manufacturing Date: Sep-2021, Expiry Date: Sep-2023
Problem Statement	The Central Drug Laboratory Karachi has analyzed the sample of Fentos 50mg Tablets (Registration No. 047810) bearing Batch No. 599, and declared it as Substandard. The company has been directed to recall the affected batch of product from the market.
Action to be taken	-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the 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) 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 healthcare institutions and hospital pharmacies. -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 if they have experienced any problems that may be related to taking or using this drug product. All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

DRAP-Recall-of-Fentos-Tablet-Hisun-batch-599Download

Recall Alert; Drug Product: Pantoloon 20mg Tablets (Batch # 5611) By M/S. Rock Pharmaceutical Laboratories (Pvt.) Ltd. Risalpur

Asad Ullah Product Recalls, Recall Alerts, Safety Info October 6, 2022November 29, 2022

Recall Alert

DRAP Alert No	NoII/S/09-22-22
Action Date	5th October, 2022
Target Audience	1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions 3. General Public
Product(s) Affected	Pantoloon 20mg Tablets, Active Ingredient(s): Pantoprazole Company: M/s. Rock Pharmaceutical Laboratories (Pvt.) Ltd. Risalpur . Batch No. 5611 Manufacturing Date: May-2022, Expiry Date: Mar-2024
Problem Statement	The Central Drug Laboratory Karachi has analyzed the sample of Pantoloon 20mg Tablets (Registration No. 095091) bearing Batch No. 5611, and declared it as Substandard. The company has been directed to recall the affected batch of product from the market.
Action to be taken	-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the 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) 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 healthcare institutions and hospital pharmacies. -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 if they have experienced any problems that may be related to taking or using this drug product. All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

Recall Alert; Drug Product: Zatranex 50mg/mL injection (Batch # 622) by M/s. Zafa Pharmaceutical Laboratories (Pvt.) Ltd., Karachi.

Asad Ullah Product Recalls, Recall Alerts, Safety Info October 6, 2022October 11, 2022

Recall Alert

DRAP Alert No	NoI/S/09-22-23
Action Date	5th October, 2022
Target Audience	1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions 3. General Public
Product(s) Affected	Zatranex 50mg/mL Injection, Active Ingredient(s): Tranexamic Acid Company: M/s. Zafa Pharmaceutical Laboratories (Pvt.) Ltd., Karachi. Batch No. 622 Manufacturing Date: April-2022, Expiry Date: April-2025
Problem Statement	The Central Drug Laboratory Karachi has analyzed the sample of Zatranex 50mg/ml Injection (Registration No. 014217) bearing Batch No. 622, and declared it as Substandard. The company has been directed to recall the affected batch of product from the market.
Action to be taken	-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the 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) 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 healthcare institutions and hospital pharmacies. -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 if they have experienced any problems that may be related to taking or using this drug product. All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

DRAP Recall Alert Zatranex Inj (Zafa) Batch 622Download

Recall Alert; Drug Product: Molimax 5mg/5ml Oral Suspension (Batch # L2165) by M/s. Alliance Pharmaceuticals Pvt Ltd, Peshawar

Ijaz Mustafa Recall Alerts August 12, 2022August 12, 2022

Recall Alert

DRAP Alert No	NoI/S/07-22-17
Action Date	6th July, 2022
Target Audience	1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions 3. General Public
Product(s) Affected	Molimax 5mg/5mL Oral Suspension, Active Ingredient(s): Domperidone Company: M/s Alliance Pharmaceuticals Pvt Ltd, Peshawar. Batch No. L2165 Manufacturing Date: January-2022, Expiry Date: December-2023
Problem Statement	The Central Drug Laboratory Karachi has analyzed the sample of Molimax 5mg/5ml Oral Suspension (Registration No. 044548) bearing Batch No. L2165, and declared it as Substandard. The company has been directed to recall the affected batch of product from the market.
Action to be taken	-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the 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) 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 healthcare institutions and hospital pharmacies. -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 if they have experienced any problems that may be related to taking or using this drug product. All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

Molimax-oral-suspension-Recall-Alert-17.Download

Falsified Alert; Drug Product: Presence of falsified Glucantime (meglumine antimonate) in market purported to be manufactured by M/s. Tillotts pharma AG, Switzerland

Ijaz Mustafa Recall Alerts August 11, 2022August 11, 2022

Falsified Alert

DRAP Alert No	NoI/S/07-22-18
Action Date	5th August, 2022
Target Audience	1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions 3. General Public
Product(s) Affected	Product Name: GLUCANTIME (Meglumine Antimoniate) Purported to be Manufactured By: TILLOTTS PHARMA AG, Switzerland Batch No. 1119-078 Manufacturing Date: December-2019, Expiry Date: November-2022
Problem Statement	Suspected falsified GLUCANTIME (Meglumine Antimoniate) has been found in in the market of Quetta, Pakistan. World Health Organization, Regulation and Safety Unit, has informed regarding the availability of falsified GLUCANTIME (Meglumine Antimoniate) purported to be manufactured by the TILLOTTS PHARMA AG, Switzerland . The stated manufacturer listed on the falsified product TILLOTTS PHARMA AG, Switzerland has confirmed that they do NOT manufactured this product and neither they sub-contract the manufacturing, nor distribute these products anywhere in the world. The following discrepancies can be identified in this falsified product:- • The outer packaging has English and French labeling but contains visible spelling mistakes and questionable information • Medicine – spelt “medecine” • Use of a Gmail email address for manufacturers contact • Statement that the product is an over the counter medicine. Pictures of Falsified GLUCANTIME (Meglumine Antimoniate) can be viewed on this link.
Action to be taken	-All Pharmacists and chemists working at distributions and Pharmacies are required to be alert and immediately inform the DRAP upon the presence of this falsified product in the market or any information related to the supply of this falsified product. -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) have also increased surveillance in the market to ensure the effective eradication of falsified product(s) and initiation of relevant legal proceedings.
Advice for Healthcare Professionals	-DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies. -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	-If anyone posses this falsified product, it is advised to not use this product9s) and shall immediately inform the DRAP. -Consumers are also advised to contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

04-Glucantime-FinalDownload

Recall Alert; Drug Product: Sterile Water for Injection (Batch # 739 and 751) by M/s. Zafa Pharmaceutical Laboratories (Pvt) Ltd., Karachi

Ijaz Mustafa Recall Alerts August 11, 2022August 11, 2022

Recall Alert

DRAP Alert No	NoI/S/07-22-18
Action Date	25th July, 2022
Target Audience	1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions 3. General Public
Product(s) Affected	Sterile Water for Injection, Company: M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd., Karachi. Batch No. 739 and 751 Manufacturing Date: February-2022, Expiry Date: February-2024
Problem Statement	The Central Drug Laboratory Karachi has analyzed the sample of Sterile Water for Injection bearing Batch No. 739 and 751 and declared it as Adulterated and Substandard. The company has been directed to recall the affected batch of product from the market.
Action to be taken	-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the 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) 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 healthcare institutions and hospital pharmacies. -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 if they have experienced any problems that may be related to taking or using this drug product. All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

Sterile-Water-for-Injetion-Zafa-Recall-Alert-18Download

Recall Alert; Drug Product: Phenerzine Elixir (Batch # 037) by M/s Epoch Pharmaceuticals (Pvt) Ltd., Karachi

Ijaz Mustafa Recall Alerts August 2, 2022August 2, 2022

Recall Alert

DRAP Alert No	NoII/S/07-22-20
Action Date	2nd August, 2022
Target Audience	1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, clinics and healthcare institutions 3. General Public
Product(s) Affected	Phenerzine Elixir, Company: M/s Epoch Pharmaceuticals (Pvt) Ltd., Karachi Batch No. 037 Manufacturing Date: March-2022, Expiry Date: March-2024
Problem Statement	The Central Drug Laboratory Karachi has analyzed the sample of Phenerzine Elixir bearing Batch No. 037 and declared it as Adulterated and Substandard. The company has been directed to recall the affected batch of product from the market.
Action to be taken	-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the 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) 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 healthcare institutions and hospital pharmacies. -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 if they have experienced any problems that may be related to taking or using this drug product. All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

Phenerzine-Elixir-Recall-Alert-20Download

Recall Alert; Drug Product: Faasgablin 75mg Capsules (Batch # 2210C001) by M/s FAAS Pharmaceuticals (Pvt) Ltd., Karachi

Ijaz Mustafa Recall Alerts August 2, 2022August 3, 2022

Recall Alert

DRAP Alert No	NoII/S/07-22-19
Action Date	28th July, 2022
Target Audience	1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, clinics and healthcare institutions 3. General Public
Product(s) Affected	Faasgablin 75mg capsules, Company: M/s FAAS Pharmaceuticals (Pvt) Ltd., Karachi Batch No. 2210C001 Manufacturing Date: January-2022, Expiry Date: January-2024
Problem Statement	The Central Drug Laboratory Karachi has analyzed the sample of Faasgablin 75mg capsules bearing Batch No. 2210C001 and declared it as Substandard. The company has been directed to recall the affected batch of product from the market.
Action to be taken	-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch(s) of product to the 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) 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 healthcare institutions and hospital pharmacies. -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 if they have experienced any problems that may be related to taking or using this drug product. All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

Faasgablin-capsules-Recall-Alert-19Download

Recall Alert: Drug Product; Water for Injection (Batch #M21421) by M/s. Vision Pharmaceuticals (Pvt.) Ltd., Islamabad.

Asad Ullah Recall Alerts June 15, 2022August 2, 2022

Recall Alert

DRAP Alert No	N0 I/S/06-22-16
Action Date	14th June, 2022
Target Audience	1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, clinics and healthcare institutions 3. General Public
Product(s) Affected	Water for Injection, Company: M/s. Vision Pharmaceuticals (Pvt.) Ltd., Islamabad Drug Registration No. 081230 Batch No. M21421, Manufacturing Date: December-2021, Expiry Date: November-2024
Problem Statement	The Central Drug Laboratory Karachi has analyzed the Water for injection bearing Batch No. M21421 4A20B27 and declared it as Substandard. The company has been directed to recall the affected batch of product from the market including pharmacies as well as the distribution setups operating in the country.
Action to be taken	All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of the product(s) to the firm. Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP 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) have also increased surveillance in the market to ensure the effective recall of defective product.
Advice for Healthcare Professionals	DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies. If anyone has used this counterfeit product, or if anyone suffers from an adverse reaction/event after having used this product, it is advised to seek immediate medical attention from a qualified healthcare professional, and to report the incident to National Pharmacovigilance Centre, DRAP using this link. All drug products must be obtained from authorized licensed sources. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

Recall Alert for Substandard Water for Injection by M/s Vision Pharmaceutical IslamabadDownload

Voluntary Recall Alert: Drug Product; Meronem 1g Injection (Batch #4A20B27 and Batch # 4A21D29) by M/S. Pfizer Pakistan Limited, Karachi

Asad Ullah Recall Alerts June 2, 2022June 15, 2022QA & LT

Voluntary Recall Alert

DRAP Alert No	N0 I/V/ 15-22-05
Action Date	18th May, 2022
Target Audience	1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 2. Healthcare Processionals- Physicians, Pharmacists and Nurses at hospitals and clinics 3. General Public
Products Affected	Meronem 1g Injection (Intravenous) , Batch No. 4A20B27, Expiry Date: August-2022 4A21D29, Expiry Date: December-2023
Problem Statement	M/s. Pfizer Pakistan Limited, Karachi has confirmed from their own sources that there is counterfeit Meronem 1gm Injection bearing Batch No. 4A20B27 and 4A21D29, in the market with similar packaging and appearance of their registered product. Due to this, M/s Pfizer Pakistan Limited has initiated a nation wide voluntary recall of 02 batches of their registered product of same batch numbers from the market up to pharmacies and distribution level. Company may be contacted at M/s Pfizer Pakistan Limited, B-2, S.I.T.E, Karachi-75700, Ph +92 (21) 32570621-5
Action to be taken	All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batches of Meronem 1g injections to the firm, company is also communicating distributors through this letter. Distributors and pharmacies are advised to be vigilant and report any suspected product(s) to the DRAP. Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance to ensure the integrity of supply chain.
Advice for Healthcare Professionals	DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies. If anyone has used this counterfeit product, or if anyone suffer an adverse reaction/event having used this product batch, it is advised to seek immediate medical advice from a qualified healthcare professional, and to report the incident to Drug Regulatory Authority of Pakistan/National Pharmacovigilance Centre using this link. All drug products must be obtained from authorized licensed sources. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

Meronem-1gm-inj-Recall-Alert-dated-18-05-22Download

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