DDCP Issues Multiple Medicine Recall and Prompt Alerts of Class-I and Class-II Categories

1. DDCP Alert No. 149/2026 — Medicine Recall (Class-I)

Notice date: 12.10.2026 | Product status: Adulterated

A. Product details

• Product name: Trezine 10mg

• Dosage form: Film Coated Tablet

• Active ingredient: Cetirizine 2HCl 10mg

• Registration number: Reg # 102590

• Batch number: 348

• Expiry date: Mar-2028

• Manufacturer: M/s BJ Pharmaceuticals

• Manufacturer’s address: 18 Km, Mandiali stop, Lahore, Sheikhupura Road, Lahore.

B. Reason for recall

• The Drug Testing Laboratory Punjab declared the product adulterated.

• The Provincial Quality Control Board, Punjab, directed the issuance of a medicine recall.

• Test report reference: TRA No. 01-75014993/DTL

• Test report date: 09.10.2026

2. DDCP Alert No. 148/2026 — Medicine Recall (Class-II)

• Notice date: 12.10.2026 | Product status: Substandard

  A. Product details

  • Product name: Ag-Tec 10mg

  • Dosage form: Film Coated Tab.

  • Active ingredient: Cetirizine Dihydrochloride 10mg

  • Registration number: Reg # 118782

  • Batch number: 003T002

  • Expiry date: Nov-2026

  • Manufacturer: M/s AGM Pharmaceuticals

  • Manufacturer’s address: 1.3 Km, Eminabad Road, Khan Payra, G.T. Road, Gujranwala, Pakistan.

  B. Reason for recall

  • The Drug Testing Laboratory Punjab declared the product substandard on the basis of the “Test for Related Substances”.

  • The Provincial Quality Control Board, Punjab, directed a recall of the affected product.

  • Test report reference: TRA No. 01-10119001588/DTL

  • Test report date: 09.10.2026

3. DDCP Alert No. 146/2026 — Medicine Recall (Class-I)

Notice date: 09.10.2026 | Product status: Substandard

A. Product details

• Product name: Prednitek 5mL

• Dosage form: Ophthalmic Suspension

• Active ingredient: Prednisolone Acetate 10mg/ml (0.1% w/v)

• Registration number: Reg # 026963

• Batch number: 7043

• Expiry date: Sep-2027

• Manufacturer: M/s Innovotek Pharmaceuticals

• Manufacturer’s address: Plot # 35, Industrial Estate Triangle, Kahuta Road, Islamabad-Pakistan.

B. Reason for recall

• • • The Drug Testing Laboratory Punjab declared the product substandard with respect to the “Sterility Test”.

    • The Provincial Quality Control Board, Punjab, directed the issuance of a medicine recall.

    • Test report reference: TRA No. 01-74018080/DTL

    • Test report date: 08.10.2026

4. DDCP Alert No. 145/2026 — Medicine Recall (Class-II)

Notice date: 09.10.2026 | Product status: Substandard

A. Product details

• Product name: Basipine–5

• Dosage form: Tablet

• Active ingredient: Amlodipine Besylate equivalent to Amlodipine 5mg

• Registration number: Reg # 087621

• Batch number: 008

• Expiry date: Mar-2028

• Manufacturer: M/s Akson Pharmaceuticals (Pvt) Ltd

• Manufacturer’s address: Plot # 9-B/1 & 2, Old Industrial Estate, Mirpur Azad Kashmir.

B. Reason for recall

• • • • The Drug Testing Laboratory Punjab declared the product substandard on the basis of “Organic Impurities”.

      • The Provincial Quality Control Board, Punjab, directed the issuance of a medicine recall.

      • Test report reference: TRA No. 01-118001870/DTL

      • Test report date: 05.10.2026

Instructions for the manufacturer, MAH, and distributor

• • • • • Immediately initiate the recall of the affected batch from the market.

        • Provide the complete distribution trail.

        • Upload the “Recall Assessment Form” on the DRAP website: Recall Assessment Form.

        • Conduct a detailed root cause analysis and prepare a Corrective and Preventive Action (CAPA) plan.

Submit all relevant information and supporting documents to the Competent Authority, Drug Regulatory Authority of Pakistan (DRAP).

5. DDCP Alert No. 147/2026 — Prompt Alert (Class-I)

Notice date: 12.10.2026 | Product status: Spurious

A. Product details

• Product name: Septi Grass Tulle

• Dosage/form and size: Dressing, 10cm × 10cm NLT5%.

• Product description: Chlorhexidine Tulle; Antiseptic Tulle Grass Dressing for Wounds.

• Declared content: Chlorhexidine Acetate 0.4%–0.6% w/w

• Registration number: Reg # MDMR-000226

• Batch number: SG-036

• Expiry date: Jan-2031

• Manufacturer: M/s Karim Industries

• Manufacturer’s address: 1/2 Km, Raiwind Lahore Road, Raiwind, District Lahore, Pakistan.

• Supply status: Government Supply

B. Reason for prompt alert

• The Drug Testing Laboratory, Punjab, declared the product spurious.

• The finding was based on the content of “Chlorhexidine Acetate” under the Drugs Act 1976.

• The Provincial Quality Control Board, Punjab, directed the issuance of a prompt alert.

• Test report reference: TRA No. 01-10119001608/DTL

• Test report date: 10.10.2026

C. Instructions for the Market Authorization Holder (MAH), importer, and distributor

• Conduct a comprehensive review of the supply chain and distribution records.

• Verify that the product has been supplied only through authorized channels.

• Immediately report any suspicious or unauthorized activity or irregularity to the respective Inspector of Drugs for Licensed/Enlisted Manufacturers of Therapeutic Goods, Punjab.

D. Instructions for healthcare professionals and regulators

• Pharmacies, medical stores, wholesalers, distributors, and healthcare facilities must immediately stop dispensing the concerned batch.

• Report current inventory and consumption records to the relevant Inspector of Drugs, Drug Inspector Distributor, or Drug Inspector of the Health Facility.

• Drug field formations in Punjab must strengthen surveillance and maintain an audit trail throughout the supply chain.

• Confiscate the product in cases of non-compliance and take regulatory action under the applicable laws and rules concerning products declared spurious under the Drugs Act, 1976.

• Submit a comprehensive report to the Chief Drugs Controller, Punjab, for onward submission to the concerned authorities.

E. Advice to consumers and the general public

• Consumers and patients are advised not to use the above-mentioned batches.

• Ensure that all therapeutic goods are obtained exclusively from authorized outlets.

F. Reporting adverse effects and contact information

• Report adverse effects associated with this product to the Provincial Pharmacovigilance Centre at mss.pshealthpunjab.gov.pk.

• Authority: Directorate of Drugs Control (DDC), Punjab

• Address: 1st Floor, Adj. to MSD, Gurumangat Road, Lahore

• Phone: +92-42-99268498

• Email: p&pvddcp.pshealth@punjab.gov.pk