URGENT MEDICINE RECALL ALERTS: DRUGS CONTROL DEPARTMENT, PUNJAB FLAGS FOUR MEDICINAL PRODUCTS AS SUBSTANDARD

Three public notices issued by the Directorate of Drugs Control, Punjab, announce the recall of four medicinal products across different therapeutic categories.
Laboratory testing has identified quality defects, including particulate contamination, glass particles, organic impurities, assay failures and bacterial endotoxins.
Healthcare professionals, pharmacies, distributors and consumers are urged to take immediate action to prevent the use and distribution of the affected batches.

Details of Recalled Therapeutic Goods

The Directorate of Drugs Control, Punjab, has issued the following medicine recall alerts:

1. DDCP Alert No. 152/2026 – Class I

Date: 20 October 2026

• Product: Injection Phyto K1 (Vitamin K1)

• Strength: 10mg/1ml

• Registration No.: 124353

• Batch No.: BBP101

• Expiry Date: January 2028

• Manufacturer: M/s Bajwa Pharmaceuticals Pvt. Ltd.

• Manufacturing Address: 36-Km, Lahore-Gujranwala Road, Khori, District Sheikhupura, Pakistan.

• Reason for Recall: Declared substandard on the basis of Particulate Contamination, Glass Particles and Assay Test.

• TRA No.: 01-141007030/DTL

• TRA Date: 19 October 2026

Background: Following reports from multiple healthcare facilities regarding discoloration of this product, a precautionary Medicine Stoppage Alert (DDCP Alert No. 137/2026, dated 23 September 2026) was previously issued. Subsequent laboratory testing confirmed that the concerned batch was substandard and unfit for use.

2. DDCP Alert No. 153/2026 – Class II

Date: 21 October 2026

Product 1: Sachet Hika 4mg

• Composition: Each sachet contains Montelukast Sodium equivalent to Montelukast 4mg.

• Registration No.: 116516

• Batch No.: 190S25

• Expiry Date: November 2027

• Manufacturer: M/s Himark Laboratories (Pvt.) Ltd.

• Manufacturing Address: 37-A, Sunder Industrial Estate, Lahore, Pakistan.

• Reason for Recall: Declared substandard on the basis of Organic Impurities and Assay Test.

• TRA No.: 01-10119002044/DTL

• TRA Date: 17 October 2026

Product 2: Film Coated Tablet Nimcid 100mg

• Composition: Nimesulide 100mg.

• Registration No.: 046336

• Batch No.: K 37

• Expiry Date: April 2028

• Manufacturer: M/s Unexolabs (Pvt.) Ltd.

• Manufacturing Address: 9.5 Km, Sheikhupura Road, Lahore, Pakistan.

• Reason for Recall: Declared substandard on the basis of Organic Impurities.

• TRA No.: 01-118002107/DTL

• TRA Date: 20 October 2026

3. DDCP Alert No. 154/2026 – Class I

Date: 27 October 2026

• Product: Injection Sterile Water 10mL Bosch

• Composition: Sterile Water for Injection.

• Registration No.: 073420

• Batch No.: WI270013

• Expiry Date: June 2030

• Manufacturer: M/s Bosch Pharmaceuticals (Pvt.) Ltd.

• Manufacturing Address: 209/23, K.I.A., Karachi, Pakistan.

• Reason for Recall: Declared substandard on the basis of Bacterial Endotoxins Test.

• TRA No.: 01-10096010562/DTL

• TRA Date: 24 October 2026

Instructions and Regulatory Directives

1. Instructions for Manufacturers, Market Authorization Holders and Distributors:

The respective Manufacturers/Market Authorization Holders (MAHs) and distributors have been directed to immediately initiate the recall of the affected batches from the market and provide the complete distribution trail. They must also upload the Recall Assessment Form on the DRAP website at https://dra.gov.pk/publications/application-forms/#Recall, conduct a detailed root cause analysis and develop a Corrective and Preventive Action (CAPA) plan. All relevant actions and supporting documentation must be submitted to the concerned Inspector of Drugs for the Licensed/Enlisted Manufacturers of Therapeutic Goods, Punjab, in the case of DDCP Alerts No. 152/2026 and 153/2026, while the documentation for DDCP Alert No. 154/2026 must be submitted to the Competent Authority, Drug Regulatory Authority of Pakistan (DRAP).

2. Instructions for Healthcare Professionals, Pharmacies and Regulators: 

Retailers, including pharmacies and medical stores, wholesalers, distributors and healthcare facilities have been directed to immediately stop the sale, supply and dispensing of the affected product batches. They must report their existing inventory and consumption records to the respective Area Drug Inspector, Drug Inspector Distributor or Drug Inspector of Health Facility. All drug field formations in Punjab have further been instructed to strengthen surveillance across the supply chain, take appropriate regulatory action under the Drugs Act 1976, the DRAP Act 2012 and the rules framed thereunder, and submit a comprehensive report to the Chief Drugs Controller, Punjab, for onward submission to the relevant authorities.

3. Instructions for Consumers, Patients and the General Public: Consumers and patients are strongly advised to immediately discontinue the use of the aforementioned affected batches, as their continued use may pose a risk to health. Healthcare professionals and the public should remain vigilant and ensure that these batches are not used or dispensed. Any adverse effect associated with the use of the recalled products must be reported to the Provincial Pharmacovigilance Centre through the Medicine Surveillance System (MSS) at https://mss.pshealthpunjab.gov.pk.

Reporting and Contact Information

Directorate of Drugs Control (DDC), Punjab
1st Floor, Adj. to MSD, Gurumangat Road, Gulberg-III, Lahore.

Phone: +92-42-99268498