FDAJanuary 21, 2025drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

What to do

FDA enforcement status: Ongoing

Brands named

harvard drug group llc dba major pharmaceuticals and rugby laboratoriesharvardharvard drug

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear