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Medicines recallMHRA

Glenmark Pharmaceuticals Europe Ltd Cyanocobalamin 50 mcg Tablets recalled over an impurity

Impurity above limitsMedium riskClass 3

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.

Check your product

Only products that match these details are covered. Have your pack in front of you.

9 identifiers listed for this notice.

  • Glenmark Pharmaceuticals Europe Ltd Cyanocobalamin 50 mcg Tablets 50

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 17231378A
    • 17231510A
    • 17231511A
    Product licenceThe PL number on the carton.
    • PL 25258/0369
    ExpiryOn the carton, blister or label.
    • 30-Nov-2024
    • 31-Dec-2024
    First distributedOn the product, its label or its packaging.
    • 01-Oct-2023
    • 14-Mar-2024
    • 17-Apr-2024

What to do now

Affected batches of Glenmark Pharmaceuticals Europe Ltd Cyanocobalamin 50 mcg Tablets contain an impurity, such as a nitrosamine, above the accepted limit.

  1. Keep taking your medicine unless a healthcare professional tells you otherwise.
  2. Check the batch number and expiry date on your pack against the list on this page.
  3. If it matches, your pharmacist can swap it or arrange an alternative.
  4. Report suspected side effects to the MHRA Yellow Card scheme.

Why it matters. Limits for impurities are set for lifetime exposure, so short-term use is unlikely to cause harm. Recalls of this kind are usually precautionary.

Symptoms and when to get help

Look out for

  • a side effect you have not had before
  • your condition not being controlled as well as usual

Get help urgently

  • signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
  • if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111

This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.

Replacements and prescriptions

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.

If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/46). Quoted as issued.

Summary

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.

The risk

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.

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.

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 .

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 .

Open the MHRA notice

Questions

Why has Glenmark Pharmaceuticals Europe Ltd Cyanocobalamin 50 mcg Tablets been recalled?

Affected batches of Glenmark Pharmaceuticals Europe Ltd Cyanocobalamin 50 mcg Tablets contain an impurity, such as a nitrosamine, above the accepted limit. Limits for impurities are set for lifetime exposure, so short-term use is unlikely to cause harm. Recalls of this kind are usually precautionary.

How do I know if my medicine is affected?

Compare the batch code, product licence, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.

What should I do now?

Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.

Do I need a new prescription?

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

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