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 reference number
DMRC-35930314
Marketing Authorisation Holder
Crescent Pharma Ltd
Medicine Details
Simvastatin 10mg Tablet
PL: 20416/0153
Active Ingredient: Simvastatin
SNOMED code: 9805211000001109
EAN: 5055382303046
GTIN: 05017123000348
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed | Livery |
|---|---|---|---|---|
| A24228 | 04/2027 | 28 Tablets | 05/02/2025 | Almus |
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.
Advice for 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.
Additional 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
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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