Recall Alert: Drug Product; Mefco 50mg/5mL Suspension (Batch # 21053) by M/s Eros Pharmaceuticals, (Pvt) Ltd, Karachi .

Recall Alert

DRAP Alert NoNoI/S/01-23-02
Action Date23rd January 2023
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 Mefco 50mg/5mL Suspension,
Active Ingredient(s): Mefenamic Acid
Company: M/s. Eros Pharmaceuticals (Pvt) Ltd, Karachi.
Batch No. 21053
Manufacturing Date: 09-2022
Expiry Date: 09-2024
Problem / Issue CDL Karachi has declared the batch No. 21053 of Mefco 50mg/5mL Suspension, manufactured by M/s. Eros 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 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; Fenbar 50mg Tablets (Batch # 2752) by M/s Usawa Pharmaceuticals, Risalpur.

Recall Alert

DRAP Alert NoNoI/S/01-23-05
Action Date25th January 2023
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 Fenbar 50mg Tablet,
Active Ingredient(s): Diclofenac Sodium
Company: M/s. Usawa Pharmaceuticals, Risalpur.
Batch No. 2752
Manufacturing Date: 04-2022
Expiry Date: 04-2025
Problem / Issue CDL Karachi has declared the batch No. 2752 of Fenbar 50mg Tablet manufactured by M/s.Usawa Pharmaceuticals, Risalpur 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 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; Paracet 1g/100mL Infusion by M/s Standpharm Pakistan Pvt Ltd, Lahore.

Recall Alert

DRAP Alert NoNoI/S/01-23-43
Action Date3rd January 2023
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 Paracet 1g/100mL Infusion,
Active Ingredient(s): Paracetamol
Company: M/s. Standpharm Pakistan Pvt Ltd, Lahore
Batch No. CIJI70
Manufacturing Date: 20-09-2022
Expiry Date: 20-09-2024
Problem / Issue CDL Karachi has declared the batch No. CIJI70 of Paracet 1g/100ml Infusion manufactured by M/s. Standpharm Pakistan (Pvt.) Ltd., Lahore as substandard & adulterated 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 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.

Voluntary Recall Alert: Drug Product; Cytotol 200mcg Tablets (Batch # 176,177,178,179,180) by M/s Saffron Pharmaceutical, Faisalabad

Voluntary Recall Alert

DRAP Alert NoNoI/S/12-22-42
Action Date20th December 2022
Target Audience1.Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
2.Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
3. General Public
Product(s) Affected Cytotol 200mcg Tablets,
Active Ingredient(s): Misoprostol
Company: M/s. Saffron Pharmaceutical Faisalabad
Batch No. 176,177,178,179,180
Problem / Issue Saffron Pharmaceuticals (Pvt.) Limited has initiated a voluntary recall of batch No. 176,177,178,179,180 of their product “Cytotol 200mcg Tablet”.
Action Initiated-The manufacturing company is recalling the defected batches 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; Tosson 0.4mg SR Capsule by M/s MTI Medical Pvt Ltd, Lahore.

Recall Alert

DRAP Alert NoNoI/S/12-22-41
Action Date5th December 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 Tosson 0.4mg SR Capsules,
Active Ingredient(s): Tamsulosin
Company: M/s. MTI Medical Pvt Ltd, Lahore
Batch No. 487
Problem / Issue DTL Lahore has declared the Batch No. 487 of Tosson SR 0.4mg Capsule manufactured by M/s. MTI medical Lahore 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 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; Ximex 100mg/5mL Suspension by Farmaceutics International Karachi

Recall Alert

DRAP Alert NoNoI/S/11-22-39
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 Ximex 100m/5mL Suspension,
Active Ingredient(s): Cefixime 100mg/5mL
Company: M/s. Farmaceutics International Karachi
Batch No. F-C-539
Manufacturing Date: 06-2022
Expiry Date: 06-2024
Problem / Issue Federal Government Analyst, CDL Karachi has declared the batch No. F-C-539 of product ‘Ximex 100mg/5mL Suspension” manufactured by M/s. Farmaceutics International Karachi, as of substandard quality based on the analysis report.
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 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; Kempol 120ml/5mL Pediatric Syrup by M/s Alkemy Pharmaceutical Laboratories Pvt Ltd Hyderabad

Recall Alert

DRAP Alert NoNoI/S/11-22-39
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 Kempol 120mg/5mL Syrup,
Active Ingredient(s): Paracetamol 120mg/5mL
Company: Ms. Alkemy Pharmaceutical Laboratories Pvt Ltd Hyderabad
Batch No. P-707
Manufacturing Date: 09-2022
Expiry Date: 08-2024
Problem / Issue Federal Government Analyst, CDL Karachi has declared the Batch No. P-707 of product ‘Kempol 120mg/5mL Syrup” manufactured by M/s. Alkemy Pharmaceutical Laboratories Pvt Ltd Hyderabad 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.

Rapid Alert: Drug Product; Falsified Restane Inhalational Solution Identified and Confiscated

Rapid Alert

DRAP Alert NoNoI/S/12-22-40
Action Date1st December 2022
Target Audience• Regulatory Field Force
• Healthcare Professionals- Anesthesiologist, Surgeons, Pharmacists, and Nurses
• Pharmacists and Chemists at Distribution, Institutional suppliers
• General Public
Problem StatementDuring the surveillance activities in different Hospitals of Punjab, Regulatory Field Force had drawn samples of this product for test/analysis. The Provincial Drugs Testing Laboratory, Faisalabad has declared the samples as spurious and adulterated.
The product detail is as under: –

Therapeutic Good Affected:-

SrProduct NameCompositionBatch #Manufactured by (as stated on label)Marketed by
(as label)
1
RESTANE Inhalation Solution 100ml
IsofluraneN0111B24
N0892A10

M/s Piramal Critical Care, Inc. Schelden Circle Bethlehem PA 18017, USA
Allied Distributors 103-K, Block-2 P.E.C.H.S, Karachi Pakistan.
Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities at Health Facilities (Hospitals) in addition to markets and confiscate these batches of product. All Pharmacists and chemists working at Hospital distributions and Pharmacies should immediately check the stock and stop supplying these batches of product. The remaining stock should be quarantined 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 products.
Advice for Healthcare Professionals-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Anesthesiologists and the supporting staff involved in surgical procedures where anesthetics are involved should remain vigilant about the suspected batches of said products.

-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-If you are intending to plan any surgeries where anesthetic procedures are involved, or you are an attendant to a such patient, you are requested to cross check the originality of this product with your healthcare professionals (e.g. physicians, surgeons, gynecologist, anesthesiologist, etc.) to ensure the originality of product.

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.