Safety alertSource: FDA Drug Enforcement Reports
Class II recall: Mylan Pharmaceuticals Inc: Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured f
Mylan Pharmaceuticals Inc. issued a Class II recall for Prasugrel Tablets, USP, 10mg, 30-count bottles, NDC 0378-5186-93. The recall was initiated because the product failed dissolution specifications, not meeting 18-month stability testing acceptance criteria.
Most relevant for: Patients prescribed prasugrel 10mg tablets from the affected Mylan lot for antiplatelet therapy.
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