Drug product
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.
D-0584-2026
Product summary
- Event
- Event 99107
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3984 bottles
- Official record key
drug-enforcement:D-0584-2026
Official wording
Reason: Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Code information: Lot #: 25282724A, Exp. Date 2027/01
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications