The Directorate of Drug Control (DDC), Punjab, ordered an immediate stoppage in the supply, sale, and use of several batches of an injectable medicine after concerns were raised about their sterility and compliance with manufacturing requirements.
The DDC, Punjab, issued the alert concerning Injection Pd-Meek 1 mL (Mecobalamin 500mcg/mL, Reg. No. 040562).
According to the public notice, the product had previously been declared “Adulterated and Standard” by the Drugs Testing Laboratory in Punjab.
A recall of the affected batches MC26020, MC26021, MC26022, MC26023, MC26024 were subsequently initiated.
During an inspection of the manufacturing facility, Drug Inspectors found that the above-mentioned batches had been released into the supply chain before completion of mandatory sterility testing, contrary to applicable Good Manufacturing Practices (GMP).
Authorities said the sterility, quality, safety and efficacy of the specified batches could therefore not currently be assured, creating a potential risk to public health.
The Provincial Quality Control Board, Punjab, has directed that a Medicine Stoppage Alert remain in place while an investigation is completed and further directions are issued.
Pharmacies, medical stores, wholesalers, distributors, healthcare facilities, and other people holding the affected batches have been directed to immediately stop their sale, purchase, dispensing, distribution, and use.
It was also told to quarantine available stocks and keep them separately, and report the stocks to the relevant Drug Inspector, Drug Inspector Distributor, or Drug Inspector of the healthcare facility.
The notice says Drug Inspectors and regulators across Punjab must ensure the alert is implemented and that available stocks are identified, secured, and sampled in accordance with the Drugs Act 1976, DRAP Act 2012 and related rules.
