Drug product
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
D-0528-2025
Product summary
- Firm
- AvKARE
- Event
- Event 97160
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 1,560 bottles
- Official record key
drug-enforcement:D-0528-2025
Official wording
Reason: Failed Impurity/Degradation Specifications
Code information: Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specifications