Drug product
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
D-0222-2018
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 78867
- Status
- Terminated
- Classification
- Class II
- Quantity
- 237 cartons
- Official record key
drug-enforcement:D-0222-2018
Official wording
Reason: Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Code information: Lot: 15270, Exp. 01/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification