Drug product
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
D-0529-2025
Product summary
- Firm
- AvKARE
- Event
- Event 97160
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 8,573 bottles
- Official record key
drug-enforcement:D-0529-2025
Official wording
Reason: Failed Impurity/Degradation Specifications
Code information: Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specifications