Drug product
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61.
D-0227-2025
Product summary
- Event
- Event 96151
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 94,349 cartons
- Official record key
drug-enforcement:D-0227-2025
Official wording
Reason: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Code information: Lot #s: N01419, N01420, N01421, Exp 03/31/2025; N01663, Exp 06/30/2025; N01664, Exp 08/31/2025; N01673, Exp 09/30/2025; N01688, Exp 08/31/2025; N01747, N01748, N01749, Exp 11/30/2025; N01792, Exp 12/31/2025; N01857, Exp 02/28/2026; N01974, Exp 05/31/2026; N02081, Exp 08/31/2026.
Distribution pattern: Nationwide U.S. and Puerto rico
Derived failure modes
-
Potency or specification failure
Out-of-specification