Class 4 Medicines Defect Notification: Simvastatin 10mg Tablet, Crescent Pharma Ltd, EL(25)A/33
Crescent Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of a batch of simvastatin 10 mg Tablets distributed by Alliance Healthcare UK.
DMRC Number: DMRC-35930314
Company name: Crescent Pharma Ltd
Product description:
Simvastatin 10mg Tablet
PL: 20416/0153
Active Ingredient: Simvastatin
SNOMED code: 9805211000001109
Details of the affected batch:
| Batch No. | Expiry Date | Pack Size | First Distributed | Livery |
| A24228 | 04/2027 | 28 Tablets | 05/02/2025 | Almus |
Brief description of problem:
Crescent Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of the above batch of Simvastatin 10 mg Tablets distributed by Alliance Healthcare UK. When scanned, the EAN barcode identifies the product as Paracetamol 250mg/5ml Oral Solution. The other product details on the carton, including the name, strength and pharmaceutical form of the medicine are correct. The quality of the medicine is not impacted by the labelling defect.
Advice to Healthcare Professionals:
Do not use this batch of medicine in robotic or automated dispensing or stocking systems. Carry out manual dispensing and stocking, as appropriate. Product quality of the Simvastatin 10mg Tablets is not impacted by this issue, therefore the affected batches are not being recalled.
Advice to Patients:
No action is needed from patients, continue to take medication from this batch as prescribed by your healthcare professional. The issue is related to the wrong barcode on the cartons of the listed batch of Simvastatin 10mg Tablets and will be controlled by the healthcare professionals prescribing/dispensing the medication. The quality of the medication is not affected.
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 medinfo@crescentpharma.com, for reporting of side effects email safety@crescentpharma.com or telephone +44 1217901596.
For stock control enquiries please email Sean.McCaul@alliance-healthcare.co.uk