MHRA Class 3 Medicines Recall: Cyanocobalamin 50 mcg Tablets (Glenmark Pharmaceuticals Europe Ltd)- Updated

Updated: 24/10/24 – the expiry date for Cyanocobalamin 50 mcg Tablets (Glenmark Pharmaceuticals Europe Ltd), batch 17231510A should be 31-Dec-2024

MHRA Class 3 Medicines Recall: Cyanocobalamin 50 mcg Tablets (Glenmark Pharmaceuticals Europe Ltd)

Drug alert number: EL(24)A/46

Date issued: 03 October 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a Class 3 medicines defect information notice for: Cyanocobalamin 50 mcg Tablets (Glenmark Pharmaceuticals Europe Ltd)

Company name: Glenmark Pharmaceuticals Europe Ltd

Product name: Cyanocobalamin 50 mcg Tablets, PL 25258/0369

SNOMED Code: N/A

Batch Number Expiry Date Pack Size First Distributed
17231378A 30-Nov-2024 50 tablets 01-Oct-2023
17231510A 31-Dec-2024 50 tablets 14-Mar-2024
17231511A 31-Dec-2024 50 tablets 17-Apr-2024

Active Pharmaceutical Ingredient: Cyanocobalamin

Brief description of the problem

Glenmark Pharmaceuticals Europe Ltd is recalling the above batches of products as stability testing and retesting results have reported that levels of Unknown Impurity do not conform with the specification limit in the Marketing Authorization of the product. The recall is at pharmacy and wholesaler level.

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.

View full alert here.

Advice for patients

No action is required by patients as this is a Pharmacy and Wholesaler level recall. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Further Information

For medical information enquiries please use the following options by phone +44 8004 580 383 or email medical_information@glenmarkpharma.com.

For stock control enquiries please email orders.uk@glenmarkpharma.com

Our CEO gives a video update addressing the prolonged pause in the 2024/25 CPCF negotiations.

Click Here