Drug Recall: Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and D
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · January 21, 2025
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.
Product Description
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61.
Distribution
Nationwide U.S. and Puerto rico
States Affected
NATIONWIDE
Quantity Affected
27,525 cartons
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0228-2025
Status: ongoing
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