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

Published On:

28 April 2022

Published In:

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

MDR number

MDR 136-03/22

Company name

Crescent Pharma Limited

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

Brief description of the 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 for 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.

To read the full article please click HERE 

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