Simvastatin 10mg Tablet
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 4 defect notification · DMRC-35930314
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Simvastatin 10mg Tablet | PL: 20416/0153 | Simvastatin | 05017123000348 |
Batches (expiry): A24228 (04/2027)
Background: 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 for Healthcare Professionals: Do not to 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.