Class 2 Medicines Recall: Crescent Pharma Limited, Paroxetine 40mg Film Coated Tablets, EL(22)A/19
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.
Further Information
For more information, medical or supply enquiries, please contact 01256 772730.
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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