Medicine recalls
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| The United Kingdom: Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Atorvastatin 20mg and 80mg Film-coated Tablets |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Sun Pharma UK Limited are recalling Atorvastatin 20 mg Film-coated Tablets (batch number: PTF6133A) and Atorvastatin 80 mg Film-coated Tablets (batch number: PTF5991D, PTF5991F) as a precautionary measure due to failing dissolution test results reported during ongoing stability studies.
The products are indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in primary hypercholesterolaemia, and to reduce total-C and LDL-C in homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments or if such treatments are unavailable. They are also used for prevention of cardiovascular events as an adjunct to correction of other risk factors.
Please refer to the following website in MHRA for details:
http://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
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Nov 12, 2025
Issued at HKT 15:45
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