Alert: Punjab recalls THESE substandard medicines from market

LAHORE: The Directorate of Drugs Control, Punjab, has issued a public notice for medicine recall and ordered the manufacturers of the products to recall the declared substandard and adulterated batches from the market.

According to the alert, the Drug Testing Laboratories Punjab declared the listed medicines as substandard and adulterated, following which the Provincial Quality Control Board directed the issuance of a recall for these medicines from the market.

Recall Medicines:

1: Injection Neudex 1mL. Dexamethasone sodium phosphate eq. to Dexamethasone phosphate 4mg/mL) Reg #042943

Batch No DX063, DX079: Expiry OCT 2027 and Batch No DX080: Expiry NOV 2027.

The above-mentioned injection was declared adulterated by Drug Testing Laboratories, Punjab.

The Directorate also recalled the following medicines, declaring them substandard based on Sterility Test:

2: Infusion Zeesol H 1000ml. (Ringer Lactate) Each 1000mL. contains: Calcium Chloride 2H2O: 0.27gms, Potassium Chloride: 0.40gms, Sodium Chloride: 6.00gms, Sodium Lactate: 3.20gms, Water for Injection: qs 2503281, Batch No 2503281, Expiry Feb-2030.

The Directorate also ordered the manufacturers of the aforementioned products to recall the concerned batches from the market and furnish the complete distribution trail, upload the “Recall Assessment Form” on the DRAP website at dra.gov.pk/publications/application-forms/Recall, conduct a detailed root cause analysis, and prepare a Corrective and Preventive Action (CAPA) plan.

The provincial Drug Control Directorate also adviced Healthcare Professionals & Regulators: Retailers (Pharmacies, Medical Stores), wholesalers, distributors, and healthcare facilities to stop dispensing of these products immediately and report the current inventory and consumption records to the respective area Drug Inspector/Drug Inspector Distributor.

All field formation in Punjab is also directed to enhance the surveillance within the supply chains and take regulatory action, in accordance with the applicable laws/rules as per Drug Act 1976/DRAP Act 2012.