FDAHealthJanuary 21, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product containe
⚠️ Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 21, 2025
Nationwide U.S. and Puerto rico
What's affected?
- 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.
- Brand
- LORAZEPAM
- Lot code
- N01419
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 94,349 cartons.
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