Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Fluorouracil Injection, 50mg/ml, solution for injection (2500mg/50ml vial), EL(22)A 08
Action Within 48 hours
Pharmacy/Wholesaler Level Recall
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
Details of the affected batch:
|
Batch number |
Expiry date |
Pack size |
First distributed |
|
L200779AA |
31st Oct 2022 |
1 x 50ml vial |
16th July 2021 |
|
D210130A |
30th Apr 2023 |
1 x 50ml vial |
1st July 2021 |
|
E210144AA |
30th Apr 2023 |
1 x 50ml vial |
9th Dec 2021 |
Active Pharmaceutical Ingredient: 5-Fluorouracil
Brief description of 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 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.
Company contacts for 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.
To access the full recall: