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 name
Posaconazole Biocon 100mg Gastro-resistant Tablets, PL 50674/0011
SNOMED Code
N/A
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| BF22004504 | Dec-24 | 12 x 8 | 27 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.
Advice for 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.
Further Information
For product quality complaints and medical information enquiries contact PQCSMV@biocon.com. For reporting adverse events contact drugsafety.smv@biocon.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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