The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product cont
Recalled February 26, 2025 · FDA recall D-0226-2025 · The Harvard Drug Group LLC
Hazard
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. · FDA Class II
Units
82,281 cartons
Sold at
Nationwide U.S. and Puerto rico
Description
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
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
Manufacturer(s)
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →