Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Fluorouracil Injection, 50 mg/ml, solution for injection (2500mg/50ml vial), EL (22)A 08
medac GmbH (t/a medac Pharma LLP) are recalling certain product batches as a precautionary measure due to visual detection of glass lamellae particles during an ongoing stability study.
MDR number
125-02/22
Company name
medac GmbH (t/a medac Pharma LLP)
Product description
Fluorouracil Injection, 50 mg/ml, solution for injection (2500mg/50ml vial) PL 11587/0015
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| L200779AA | 31 October 2022 | 1 x 50ml vial | 16 July 2021 |
| D210130A | 30 April 2023 | 1 x 50ml vial | 01 July 2021 |
| E210144AA | 30 April 2023 | 1 x 50ml vial | 09 December 2021 |
Active Pharmaceutical Ingredient: 5-Fluorouracil
Brief description of the problem
medac GmbH (t/a medac Pharma LLP) are recalling the above batches as a precautionary measure due to visual detection of glass lamellae particles during an ongoing stability study.
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.
Further Information
For more information, medical or supply enquiries, please contact medac Pharma LLP by email to info@medacpharma.co.uk or telephone 01786 458086.
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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