FDA recall D-0227-2025

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Class II · drug

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.

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

Key facts

Status
Ongoing
Initiation date
2025-01-21
Report date
2025-02-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
La Vergne, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0227-2025