MHRA 发布 Class 3 药品召回：Sun Pharmaceutical 阿托伐他汀 20mg 与 80mg 薄膜衣片 EL(25)A/48

Contents

1. DMRC reference number
2. Marketing Authorisation Holder
3. Medicine Details
   1. Atorvastatin 20 mg Film-coated Tablets
4. Affected Lot Batch Numbers
5. Medicine Details
   1. Atorvastatin 80 mg Film-coated Tablets
6. Affected Lot Batch Numbers
7. Background
8. Advice for Healthcare Professionals
9. Advice for Healthcare Professionals to Provide to Patients
10. Additional information
11. Download document

DMRC reference number

DMRC - 37494064

Marketing Authorisation Holder

Sun Pharmaceutical Industries Limited

Medicine Details

Atorvastatin 20 mg Film-coated Tablets

PL: 14894/0714

Active Ingredient: atorvastatin calcium trihydrate

SNOMED code: 22940911000001103

GTIN: 05015525012327

Affected Lot Batch Numbers

Medicine Details

Atorvastatin 80 mg Film-coated Tablets

PL:14894/0716

Active Ingredient: atorvastatin calcium trihydrate

SNOMED code: 22941511000001103

GTIN: 05015525012341

Affected Lot Batch Numbers

Background

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 for 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 for Healthcare Professionals to Provide 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.

Additional information:

For all medical information enquiries and information on this product, please email [email protected], or telephone 020 8848 5050 / 07974754551.

For stock control enquiries please email [email protected], or telephone 020 8848 5050.

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

[email protected]

Download document

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