Class 2

Class 2 Medicines Recall: Crescent Pharma Limited, Paroxetine 40mg Film Coated Tablets, EL(22)A/19

Crescent Pharma Limited are recalling Paroxetine 40mg Film Coated Tablets as a precautionary measure.

MDR Number: MDR 136-03/22

Company name: Crescent Pharma Limited

Product description: Paroxetine 40mg Film Coated Tablets PL 20416/0363

Details of the affected batch:

Batch number

Expiry date

Pack size

First distributed

06309

September 2023

30 tablets

19 Feb 2021

Brief description of problem:

Crescent Pharma Limited are 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.

Advice to Healthcare Professionals:

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Advice for patients:

  • This is a precautionary Pharmacy and Wholesaler level recall, therefore no further action is required by patients.
  • 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.

Company contacts for further information:

For more information, medical or supply enquiries, please contact 01256 772730.

To access the full recall: Class 2 Medicines Recall: Crescent Pharma Limited, Paroxetine 40mg Film Coated Tablets, EL(22)A/19