Rapid Alert: Drug Product; Falsified Tablin 300mg Capsule identified in the market

Rapid Alert

Suspected Falsified Product

DRAP Alert NoNoI/S/10-22-36
Action Date24th November 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 District Sheikhupura Punjab, Regulatory Field Force has identified the suspected sample for product and sent for analysis to laboratory. The Provincial Drugs Testing Laboratory, has declared the samples as “spurious”. The stated manufacturers on the label has informed that they have not manufactured this batch number of product.
Product detail is as under:-

Therapeutic Good Affected:-

SrProduct NameCompositionBatch #Manufactured by (as stated on label)
1TABLIN 300mg Capsule
Pregabalin 300mgBatch No. 699M/s Theramed Pharmaceuticals (Pvt) Ltd, Lahore.
Action InitiatedThe Regulatory Field Force has been directed to increase the market surveillance and confiscate this batch of the 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 product.

-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.

-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.

Recall Alert: Drug Product; Ponstan Forte 500mg Tablets (Batch # 2050533) by M/s Pfizer Pakistan Ltd, Karachi.

Recall Alert

DRAP Alert NoNoI/S/10-22-35
Action Date30th November 2022
Target Audience1. 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 Ponstan Forte 500mg Tablets,
Active Ingredient(s): Mefenamic Acid
Company: M/s. Pfizer Pakistan Ltd, Karachi
Batch No. 2050533
Manufacturing Date: 09-2020
Expiry Date: 08-2025
Problem / Issue The Drug Testing Laboratory, Baluchistan has analyzed the sample of batch No. 2050533 of Ponstan Forte 500mg Tablets manufactured by M/s. Pfizer Pakistan Ltd Karachi, Pakistan and declared it as “Substandard” based on the analysis.
Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

-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; Diamicron 80mg Tablets (Batch#1740) by M/s. Servier Research & Pharmaceuticals Pakistan (Pvt) Ltd Lahore.

Recall Alert

DRAP Alert NoNoII/S/10-22-33
Action Date23rd November 2022
Target Audience1. 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 Diamicron 80mg Tablets,
Active Ingredient(s): Gliclazide
Company: M/s. Servier Research & Pharmaceuticals Pakistan (Pvt) Ltd Lahore.
Batch No. 1740
Manufacturing Date: 04-2022
Expiry Date: 04-2025
Problem / Issue Central Drug Laboratory, Karachi has analyzed the samples of Diamicron 80mg Tablets manufactured by M/s Servier Research & Pharmaceuticals Pakistan (Pvt) Ltd Lahore and declared the batch No. 1740 as “substandard” based on the analysis report.
Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

-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.

Rapid Alert: Drug Product; Falsified Xanax 0.5mg Tablets identified in the market

Rapid Alert

Suspected Falsified Product

DRAP Alert NoNoI/S/11-22-37
Action Date28th November 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 Ferozewala District Sheikhupura Punjab, Regulatory Field Force has identified the suspected sample of Xanax 0.5mg Tablets and sent for analysis. The Provincial Drugs Testing Laboratory, has declared the samples as “spurious” based on the analysis report. Details of the falsified product is as under: –

Therapeutic Good(s) Affected:-

SrProduct NameCompositionBatch #Manufactured by (as stated on label)
1Xanax 0.5mg TabletAlprazolam 0.5mgFM7597M/s Pfizer Pakistan Ltd,
B-2, S.I.T.E, Karachi.
Action InitiatedThe Regulatory Field Force has been directed to increase the market surveillance and confiscate this batch of the 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 this falsified product.
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of above-mentioned product(s).

-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.

-Please click here for further information on reporting problems 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 only 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; Moxtrex 400mg Tablets (Batch # 850) by M/s Gillman Pharmaceuticals, Hattar, Khyber Pakhtunkhwa

Recall Alert

DRAP Alert NoNoII/S/10-22-32
Action Date3rd November 2022
Target Audience1. 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 Moxtrex 400mg Tablets,
Active Ingredient(s): Moxifloxacin
Company: M/s Gillman Pharmaceuticals, Hattar.
Batch No. 850
Manufacturing Date: 06-2022
Expiry Date: 06-2024
Problem / Issue Drug Testing Laboratory (DTL) Rawalpindi has analyzed the samples of Moxtrex 400mg Tablets manufactured by M/s Gillman Pharmaceuticals, Hattar, KPK and declared the batch No. 850 as “substandard” based on the analysis report.
Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

-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; Ceficure 400mg Capsules (Batch # C-737) by M/s Max Pharmaceuticals Islamabad

Recall Alert

DRAP Alert NoNoII/S/10-22-30
Action Date2nd November 2022
Target Audience1. 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 Ceficure 400mg Capsules,
Active Ingredient(s): Cefixime
Company: M/s MAX Pharmaceuticals, Islamabad.
Batch No. C-737
Manufacturing Date: 06-2022
Expiry Date: 05-2024
Problem / Issue The Drug Testing Laboratory (DTL), Rawalpindi has analyzed the sample of batch No. C-737 of Ceficure 400mg Capsule manufactured by M/s. Max Pharmaceutical, Islamabad, and declared it as “misbranded” drug product.
Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

-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; Telsarta 40mg Tablets (Batch # 2B151) by M/s PharmEvo Pharmaceuticals Pvt Ltd. Karachi

Recall Alert

DRAP Alert NoNoII/S/10-22-31
Action Date2nd November 2022
Target Audience1. 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 Telsarta 40mg Tablets,
Active Ingredient(s): Telmisartan
Company: M/s PharmEvo Pharmaceuticals Pvt, Ltd. Karachi
Batch No. 2B151
Manufacturing Date: 02-2022
Expiry Date: 01-2024
Problem / Issue Drug Testing Laboratory (DTL) Rawalpindi has analyzed the samples of Telsarta 40mg Tablets manufactured by M/s PharmEvo Pharmaceuticals Pvt Ltd, Karachi and declared the batch No. 2B151 as “substandard” based on the analysis report.
Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

-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.

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.