FDAHealthJanuary 21, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contai
⚠️ 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, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61
- Brand
- LORAZEPAM
- Lot code
- N01424
Additional details
Lot #s: N01424, N01425, Exp 03/31/2025; N01659, N01660, Exp 08/31/2025; N01668, 09/2025; N01679, N01704, N01745, Exp 10/31/2025; N01856, Exp 02/28/2026; N01973, Exp 05/31/2026; N02079, Exp 08/31/2026.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 82,281 cartons.
Get Health recall alerts
Delivered to your inbox. Free. No account required.