Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Atorvastatin 20mg and 80mg Film-coated Tablets, EL(25)A/48

Sun Pharma UK Limited are recalling the batches of tablets specified in the table as a precautionary measure due to failing dissolution test results reported during ongoing stability studies.

DMRC Number: DMRC - 37494064

Company name:Sun Pharmaceutical Industries Limited

Product descriptions: 

Atorvastatin 20 mg Film-coated Tablets - PL: 14894/0714, SNOMED code: 22940911000001103, GTIN: 05015525012327

Atorvastatin 80 mg Film-coated Tablets - PL:14894/0716, SNOMED code: 22941511000001103, GTIN: 05015525012341

Background information: 

Sun Pharma UK Limited are recalling the batches of tablets specified in the table as a precautionary measure due to failing dissolution test results reported during ongoing stability studies.

Advice to Healthcare Professionals: 

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Advice to Patients: 

Patients should continue to take medicines as prescribed by your healthcare professional. The recall is being actioned at the wholesaler level as a precautionary measure. No complaints of harm or lack of efficacy have been received from patients regarding this batch.

Patients who experience adverse reactions or have any questions about their 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 all medical information enquiries and information on this product, please email Cserv.uk@sunpharma.com, or telephone 020 8848 5050 / 07974754551.

For stock control enquiries please email Cserv.uk@sunpharma.com, or telephone 020 8848 5050.

To access the full recall/alert: Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Atorvastatin 20mg and 80mg Film-coated Tablets, EL(25)A/48