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Recall Observatory FDA recall evidence

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

January 21, 2025

Class II

Product summary

Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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

    reason.potency_specification_failure · v1.0.0

    Out-of-specification