Class 3 Medicines Recall: Biocon Pharma UK Ltd., Posaconazole Biocon 100mg Gastro-resistant Tablets, EL(23)A/44

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.

MDR Number: MDR 090-12/23

Company name: Biocon Pharma UK Limited.

Product description: Posaconazole Biocon 100mg Gastro-resistant Tablets, PL 50674/0011

Details of the affected batch:

Brief description of 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 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 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.

Company contacts for further information:

For product quality complaints and medical information enquiries contact PQCSMV@biocon.com. For reporting adverse events contact drugsafety.smv@biocon.com     

To access the full recall: Class 3 Medicines Recall: Biocon Pharma UK Ltd., Posaconazole Biocon 100mg Gastro-resistant Tablets, EL(23)A/44