Update: Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd

Update: Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd Cyanocobalamin 50 mcg Tablets, EL(24)A/46

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.

This recall notification has been updated since its initial publication on 3 October 2024 to include the correct batch information for Cyanocobalamin 50 mcg Tablets, batch 17231510A. Glenmark Pharmaceuticals Europe Ltd. erroneously provided incorrect information pertaining the expiry date of batch 17231510A and have ensured that all other batch information is correct. Please ensure that appropriate action is taken to ensure this batch is recalled.

DMRC Number: DMRC-31522269

Company name: Glenmark Pharmaceuticals Europe Ltd

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

SNOMED Code: N/A

Details of the affected batch: 

Active Pharmaceutical Ingredient: cyanocobalamin

Brief description of 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 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.

Advice to 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.

Company contacts for 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

To access the full recall: 

Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd Cyanocobalamin 50 mcg Tablets, EL(24)A/46

Original recall details:  03/10/2024

Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd Cyanocobalamin 50 mcg Tablets, EL(24)A/46

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.

DMRC Number: DMRC-31522269

Company name: Glenmark Pharmaceuticals Europe Ltd

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

SNOMED Code: N/A

Details of the affected batch: 

Active Pharmaceutical Ingredient: cyanocobalamin

Brief description of 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 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.

Advice to 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.

Company contacts for 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

To access the full recall: 

Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd Cyanocobalamin 50 mcg Tablets, EL(24)A/46