Class 3 Medicines Recall: Tamoxifen 20mg Film-Coated Tablets, Wockhardt UK Ltd, EL(25)A/31
Wockhardt UK Limited is recalling a batch as a precautionary measure following the identification of a dissolution failure during stability testing.
DMRC reference number
DMRC-35980389
Marketing Authorisation Holder
Wockhardt UK Ltd
Medicine Details
Tamoxifen 20mg Film-Coated Tablets
PL: 29831/0195
Active ingredient: tamoxifen citrate
SNOMED code: 659711000001107
GTIN: 15012727402205
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| HZ10030 | 30/04/2027 | 30 | 22/08/2024 |
Background
Wockhardt UK Limited is recalling the above batch as a precautionary measure following the identification of a dissolution failure during 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:
Patients should continue to take medicines as prescribed by your healthcare professional. The recall is being actioned at the pharmacy and wholesaler level as a precautionary measure. No complaints of harm or lack of efficacy have been received from patients regarding this batch.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Additional information:
For medical information enquiries please email drug.safety@wockhardt.co.uk, or telephone 01978 661261 and ask for ‘drug safety’.
For stock control enquiries please email group_uk_csu@wockhardt.co.uk, or telephone 01978 661261and ask for ‘customer services’.
Recipients of this Medicines Notification 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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