Class II
Ongoing
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
This recall is currently active, issued February 26, 2025. It was issued by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories.
- Recall Initiated
- January 21, 2025
- Posted
- February 26, 2025
- Recall Number
- D-0226-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 82,281 cartons
- Firm Location
- La Vergne, TN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Distribution
Nationwide U.S. and Puerto rico
Lot / Code Info
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.
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