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
Cyanocobalamin 50 mcg Tablets, PL 25258/0369
SNOMED Code: N/A
| Batch No | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 17231378A | 30-Nov-2024 | 50 | 01-Oct-2023 |
| 17231510A | 31-Dec-2024 | 50 | 14-Mar-2024 |
| 17231511A | 31-Dec-2024 | 50 | 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.
Advice for patients
No further 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
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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Updates to this page
Published 3 October 2024Last updated 24 October 2024 + show all updates
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This recall notification has been updated since its initial publication on 3rd of 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.
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First published.