MHRA Class 3 Medicines Recall: Posaconazole Biocon 100mg Gastro-resistant Tablets (Biocon Pharma UK Limited)

Drug alert number: EL (23)A/44

Date issued: 14 December 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 3 medicines recall for: Posaconazole Biocon 100mg Gastro-resistant Tablets (Biocon Pharma UK Limited) PL 50674/0011

SNOMED Code: N/A

Batch Number Expiry Date Pack Size First Distributed
BF22004504 Dec-2024 12 x 8 27th April 2023

Active Pharmaceutical Ingredient: Posaconazole

Brief description of the problem

Biocon Pharma UK Limited are recalling a specific of batch Posaconazole 100mg Gastro-resistant Tablets due to an out of trend result for unspecified impurities during testing for stability. The batch is likely to be out of specification before the expiry date and therefore the batch is being recalled as precautionary measure.

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.

Full drug alert can be viewed here.

Advice for patients and carers

No further action is required by patients, these batches are being recalled at the pharmacy and wholesaler level as a precautionary measure. 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 product quality complaints and medical information enquiries contact PQCSMV@biocon.com. For reporting adverse events contact drugsafety.smv@biocon.com.

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