ISLAMABAD:Drug Regulatory Authority of Pakistan (DRAP) has directed a drug manufacturing company to immediately recall its defected batch of a product from the market.
According to a recall alert issued by DRAP, all pharmacists and chemists working at distributions and pharmacies have been asked to immediately return the stock of a batch of product to the supplier, importer, and the company.
The Central Drugs Laboratory Karachi had declared that batch No. CIJI70 of Paracet 1g/100ml Infusion, active ingredients of Paracetamol, manufactured by M/s. Standpharm Pakistan (Pvt.) Ltd., Lahore as a substandard and adulterated drug product with a manufacturing date of September 20, 2022, and expiry date of September 20, 2024.
All concerned distributors and pharmacies have been advised to be vigilant and report any suspected batch of product in the supply chain to the DRAP using the online form, or through phone at +92 5191073-17, or Email at [email protected].
The authority advised the consumers and the general public to stop using this product bearing the affected batch numbers and contact their physician or healthcare provider if they have experienced any problems related to taking or using this drug product, and report the incident to DRAP’s National Pharmacovigilance Centre.
It said all therapeutic goods must be obtained from licensed pharmacies and other authorized retail outlets. The authenticity and condition of products should be carefully checked and seek advice from pharmacists or other healthcare professionals in case of any doubt, it added.
The authority also asked that any adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre (NPC), DRAP using the adverse event reporting form or online through this link. It added further information on reporting problems to DRAP is available at the link which is: https://www.dra.gov.pk/safety-information/safety-communication/report-a-problem/
The regulatory field force of all federating units, including DRAP, provincial health departments, and states have increased surveillance in the market to ensure the effective recall of a defective drug product.
The alert was issued for pharmacists and chemists at distributions, pharmacies, and medical stores, and healthcare professionals, including physicians, pharmacists, and nurses at hospitals, clinics, and healthcare providing Institutions besides the general public.