Suspected Falsified Alert; Drug Products; Suspected Anti-D Immunoglobulin Injection in the market

Rapid Alert

DRAP Alert NoNoI/S/10-22-29
Action Date28th October 2022
Target Audience1. 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 StatementDRAP received a complaint regarding the presence of following suspected product in the market. This product is not imported and marketed by the authorized registration holder and neither DRAP has issued import clearance for this product. National Control Laboratory for Biological has also not issued any lot release to this product.
SrProduct NameCompositionBatch #Manufactured by (as stated on label)
101 IMMUNORHO 300µg (1.500iu)
(PFS; Pre-filled syringe)
Human anti-D immunoglobulinM05W25212M/s. KEDRION BIOPHARMA.
Action InitiatedThe Regulatory Field Force has been directed to increase the market surveillance and confiscate this product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this product. The remaining stock should be quarantine immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) in order to ensure the removal of suspected products.
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 this product 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.
Pictures of Suspected falsified product

Regulatory Update / Advisory; Recall of Targocid 200mg powder for solution for injection/infusion or oral solution in UK

Date:   31st October, 2022

Target Audience: –  

  • Healthcare Professionals- Physicians, Pharmacists, and Nurses.
  • General Public

Problem or Issue: –

Sanofi UK has initiated an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution (Batch Number 0J25D1 and Batch Number 0J25D2). Reason for recall is the out of specifications results obtained for bacterial endotoxins in the retained samples.

However, both of these batches were not imported or marketed in Pakistan by the authorized registration holder company, hence, Pakistan’s market will not be affected by this recall operation.

Nonetheless, DRAP has directed registration holder company to test the retaining samples of other batches which are supplied in Pakistan to ensure that problem is not extended beyond the identified two batches.  

Advice for healthcare professional: –

Healthcare professionals should be aware of the clinical symptoms related to the potential risk to patient health; a high temperature (fever) or low body temperature, chills and shivering, cold, clammy and pale or mottled skin, a fast heartbeat, fast breathing, severe breathlessness, severe muscle pain, feeling dizzy or faint, a change in mental state – such as confusion or disorientation, loss of consciousness, slurred speech, nausea and vomiting and/or diarrhea.

Adverse reactions or quality problems experienced with the use of this product shall be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.  Further information on how to report a problem to DRAP is available on this link.

Advice for general public: –

Since, these affected batches have not been imported or supplied in Pakistan by the marketing authorization holder, no recall is initiated for this product in Pakistan. These these batches were supplied and being recalled in the UK market only. However, if any person has carried these affected batches for their personal use they are advised not to consume it, and consult their healthcare provider immediately.

Suspected Falsified Alert; Drug Products; Regulatory Field Force reported the presence of suspected falsified products in market

Suspected Falsified Alert

DRAP Alert NoNoI/S/10-22-28
Action Date25th October, 2022
Target Audience1. 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 StatementDuring the market surveillance activities in different areas of Karachi, Provincial Drug Inspectors from Karachi have identified the suspected samples of products and sent for analysis to Drug Testing Laboratories. The Provincial Drugs Testing Laboratory, Sindh, Karachi has declared the samples of following products as spurious. The stated manufacturers on the labels of these products has informed that they have not manufactured these batches. Details are as under: –
SrProduct NameBatch #PURPORTED TO BE MANUFACTURED BY
1Cap Rulling 40mg4RU083M/s. High-Q Pharma Karachi.
2Cap Eskeem 40mg4EK086-do-
3Cap Mixel 400mg4MX120-do-
4Tab Dicloran 50mg002HM/s. Sami Pharma Karachi
5Inj Meronem IV 1g4A21D282
4A21H02
4B21K26
M/s. ACS Doblar & packed by Ms. Pfizer Pakistan Ltd.
6Inj. Tanzo 2.25gPN20148M/s. Bosch Pharma Karachi
7Inj. PENRO 500mgPO210047-do-
8Tab. Ciproxin 500mgBAA058M/s. Bayer Pakistan Ltd Karachi
9Cap Azomax 250PMSAM/s. GlaxoSmithKline Ltd.
10Tab. Relief Extra Finished
(Packed strips)
Not mentionedM/s. Combitic Global Caplet, India
Action InitiatedThe Regulatory Field Force has been directed to increase the market surveillance and confiscate these batches of above-mentioned products. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying these batches of products. The remining stock should be quarantine immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) in order to ensure the removal of above-mentioned batches of products.
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 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 any these drug products, 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.

Recall Alert: Drug Product; Sterile Water for Injection (Batch # 440) By M/s. Karachi Pharmaceutical Laboratories, Karachi

Recall Alert

DRAP Alert NoNoI/S/10-22-29
Action Date20th October, 2022
Target Audience1. 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. Karachi Pharmaceutical Laboratories, Karachi
Batch No. 440
Manufacturing Date: June-2022,
Expiry Date: June-2025
Problem StatementThe Central Drug Laboratory Karachi has analyzed the sample of Sterile Water for Injection (Registration No. 012570) bearing Batch No. 440, 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; Human Albumin 20% 100mL (Batch/Lot # C236821P02) Manufactured By M/s. Biotest Pharma GmbH

Recall Alert

DRAP Alert NoNoI/S/10-22-25
Action Date7th October 2022
Target Audience1. 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 Human Albumin 20% 100mL (Biotest),
Active Ingredient(s): Serum Albumin 20% (Human)
Company: M/s. Biotest Pharma GmbH, Germany imported by M/s Eastren Trade & Distribution Co, (Pvt) Limited, Karachi
Batch No. C236831P02
Manufacturing Date: 17-Sep-2021,
Expiry Date: 31-Aug-2024
Problem StatementDRAP has received a rapid alert from the Paul-Ehrlich Institut, Federal Institue of Vaccine and Biomedicines, Ministry of Health, Germany, with respect to the quality defect and voluntary recall of 06 batches of Human Albumin 20%, 100mL manufactured by the Botest AG, GmbH. Out of these six batches, one batch was imported in Pakistan by the authorized registration holder M/s Eastren Trade & Distribution Co, (Pvt) Limited, Karachi.
Action InitiatedThe importer has been directed to immediately recall the stock of defective batch C236831P02 from the market. Regulatory field force is directed to supervise the recall progress.

-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / 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 Alert: Drug Product; Fentos 50mg Tablets (Batch # 599) By M/s. Hisun Pharmaceutical Industries, Gadoon-Pakistan

Recall Alert

DRAP Alert NoNoII/S/09-22-21
Action Date6th October, 2022
Target Audience1. 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 StatementThe 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.

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

Recall Alert

DRAP Alert NoNoII/S/09-22-22
Action Date5th October, 2022
Target Audience1. 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 StatementThe 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.

Recall Alert

DRAP Alert NoNoI/S/09-22-23
Action Date5th October, 2022
Target Audience1. 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 StatementThe 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.

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

Recall Alert

DRAP Alert NoNoI/S/07-22-17
Action Date6th July, 2022
Target Audience1. 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 StatementThe 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.

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

Falsified Alert

DRAP Alert NoNoI/S/07-22-18
Action Date5th August, 2022
Target Audience1. 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 StatementSuspected 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.