ISLAMABAD: The Drug Regulatory Authority Pakistan (DRAP) has issued a recall alert for Flagyl Injection Batch No Ad482 manufactured by Sanofi Aventis Pakistan Limited, Karachi, owing to substandard quality.
According to an official notification issued here on Tuesday, the DRAP announced that following information by the senior drug inspector Islamabad Capital Territory (ICT) that samples of abovementioned product has been reported substandard by Drug Testing Laboratory (DTL) Rawalpindi and the use of the product could harm the patients.
According to DRAP “endotoxin containing intravenous products can lead to a range of consequences, including fever, chills, shock, organ failure, which can even prove fatal. Even small amounts of endotoxin in an injection can cause significant harm, particularly in vulnerable individuals like immunocompromised patients or those with pre-existing medical conditions”.
The DRAP following the information started a crackdown against the substandard products by issuing recall alerts and directing the National Regulatory Field Force (NRFF), provincial drug control departments, pharmacists, chemists in distribution, pharmacies/medical stores, healthcare professionals- physicians, pharmacists, nurses at hospitals/clinics general public to stop the use of purchase, sale, prescription and use of following drugs.
The manufacturers are directed to immediately recall the defective batches of products from the market. The field force under the administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of the presence and removal of the mentioned batches from the market.
The regulatory field force of DRAP and provincial drug control departments have been directed to immediately conduct market surveys for detection and removal of these products from the market.
All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products.
The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.
Copyright Business Recorder, 2025
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