Sun Pharma UK Limited has issued a precautionary recall of specific batches of their Atorvastatin 20mg and 80mg film-coated tablets. The decision follows dissolution test failures observed during ongoing stability studies. Clinical teams, quality assurance professionals, and regulatory experts should take necessary action for patient safety and compliance.
Overview of the Issue
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a Class 3 medicines recall involving Sun Pharma’s Atorvastatin tablets. Dissolution tests during routine stability checks revealed non-compliance with established performance criteria. This recalls emphasizes Sun Pharma’s proactive approach to upholding public health and patient safety.
Affected Batches
The recall is specific to batches of Atorvastatin 20mg and 80mg film-coated tablets manufactured by Sun Pharma UK Limited. These are prominent cholesterol-control medicines in widespread use. Healthcare providers are required to check inventories promptly and comply with recall instructions.
Key Facts:
- Product: Atorvastatin film-coated tablets
- Strengths: 20mg, 80mg
- Issue: Dissolution test failures during stability studies
Further details on batch numbers and return procedures are outlined in Sun Pharma’s communication to supply chain parties.
Why This Matters
Atorvastatin tablets are commonly prescribed for managing high cholesterol and reducing cardiovascular risks. Medicines found inconsistent in dissolution can impact therapeutic efficacy. The MHRA’s recall ensures these batches are swiftly removed from circulation to prevent risk escalation.
Who Is Affected?
- Pharmacies stocking impacted batches
- Distribution networks handling these medicines
- Healthcare providers prescribing or dispensing Atorvastatin
Teams in clinical, regulatory, and quality areas must coordinate closely to execute the recall procedures efficiently.
FAQ
- What is a Class 3 recall?
A Class 3 recall involves medicines that pose a low risk to patients but require action to maintain quality standards. - What are dissolution test failures?
Dissolution failures occur when tablets do not release their active ingredient at the expected rate during stability testing. - Are patients at immediate risk?
No significant safety concerns for patients have been reported. The recall is a precautionary safety measure. - How should pharmacies respond?
Pharmacies should identify affected batches and follow Sun Pharma’s recall instructions for return and disposal.
Next Steps
Regulatory and clinical teams should prioritize compliance with the recall announcement. Healthcare providers must verify inventories, alert staff, and ensure affected products are removed systematically. This recall emphasizes the importance of stability studies in maintaining medication performance and safety.
Disclaimer
This article is meant for professional regulatory guidance. It is not legal advice. Healthcare professionals should rely on official recall documents and MHRA updates to inform their decisions.
For full information about the announcement, see the link below.
https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-sun-pharmaceutical-industries-limited-atorvastatin-20mg-and-80mg-film-coated-tablets-el-25-a-slash-48