Lannett Company Inc.: Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, ND
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Lannett Company Inc.
- 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.
- Reason / hazard
- Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the United States
- Recall initiated
- 2026-05-27
- Code info
- Lot #: 25282724A, Exp. Date 2027/01
- Product quantity
- 3984 bottles
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Seymour
- State
- IN
- Country
- United States
- Event id
- 99107
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