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

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 30-Nov-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 affected batches as a precautionary measure due to out of specification results for unknown impurities during routine stability testing and additional re-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.

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