The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories: Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained

Hazard

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

Details from the source

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 Quantity: 27,525 cartons Lot/code info: Lot #s: N01422, N01423, Exp 03/31/2025; N01661, N01662, Exp 09/30/2025; N01746, N01750, Exp 10/31/2025; N01876, N01877, Exp 03/31/2026; N01899, N01900, N01975, Exp 04/30/2026.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.