FDA-Drug2025-02-26Class II
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.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Hazard
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Sold states
Nationwide U.S. and Puerto rico
Affected count
94,349 cartons
Manufactured in
341 Mason Rd, N/A, La Vergne, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0227-2025Don't want to check this manually?
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