The Pharmacy and Poisons Board (PBP) has announced the recall of Flamodip (Amlodipine) 5mg Tablets, Batch No. FLD303, manufactured by Medico Remedies Pvt Limited.
The recall has been prompted by a labelling error that affects both the primary and secondary packaging of the product.
“The recall has been initiated due to a labeling error, where the product’s label does not accurately reflect its contents. The secondary packaging is labeled as Flamodip-5 (Amlodipine), while the primary packaging is labeled as Flaminopril-5 (Enalapril).” A statement by the board reads in part.
Pharmaceutical outlets, healthcare facilities, and healthcare professionals have been advised to immediately cease distribution, sale, and use of the affected product batch.
They are also instructed to return the product to their nearest healthcare facility or respective suppliers.
Members of the public have been urged to stop using the affected batch and return it as well.
“In light of the above, the board advises all pharmaceutical outlets, healthcare facilities, healthcare professionals, and members of the public to stop further distribution, sale, issuing, or use of the product batch and return the product to their nearest healthcare facility or respective suppliers.” The statement added.
The board further encourages the public to report any cases of suspected substandard medicines or adverse drug reactions to health facilities and the Pharmacy and Poisons Board.
“The Board encourages the public to promptly report any suspected cases of substandard medicines or adverse drug reactions to the nearest healthcare facility or the Pharmacy and Poisons Board.” The statement concluded.
Amlodipine is a calcium channel blocker used to treat high blood pressure (hypertension). It can help prevent future heart disease, heart attacks, and strokes. It is also used to prevent chest pain (angina) caused by heart disease.
Amlodipine works by relaxing and widening blood vessels, which lowers blood pressure and makes it easier for the heart to pump blood around the body.
