Drug product
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13
D-0306-2025
Product summary
- Event
- Event 96496
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2184 bottles
- Official record key
drug-enforcement:D-0306-2025
Official wording
Reason: Failed dissolution specifications: lower than specifications
Code information: Lot#: AVC24035, Exp 03/31/26
Distribution pattern: U.S.A. nationwide
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications