The Medicines and Healthcare products Regulatory Agency (MHRA) has advised healthcare professionals to stop supplying a specific batch of Paroxetine 40mg Film Coated Tablets immediately.
Crescent Pharma Limited is recalling a specific batch of Paroxetine 40mg Film Coated Tablets as a precautionary measure due to out of specification results for dissolution during routine stability testing.
“Quarantine all remaining stock of the said batch and return it to your supplier, using your supplier’s approved process,” said MHRA.
The agency alerted the patients that this is a precautionary Pharmacy and Wholesaler level recall, therefore no further action is required by patients.
It added, “Patients should continue taking your medicines from this batch, as stopping paroxetine treatment abruptly is likely to cause harm.The Marketing Authorisation Holder have not received any reports of adverse reactions related to the issue above, however, patients who experience a change of their condition or symptoms or any adverse reactions should seek medical attention. These should also be reported via the MHRA Yellow Card scheme.”
Product name: Paroxetine 40mg Film Coated Tablets PL 20416/0363
|Batch number||Expiry date||Pack size||First distributed|
|06309||September 2023||30 tablets||
19 Feb 2021
Active Pharmaceutical Ingredient: paroxetine