Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this packa…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Imp…
- Status
- Ongoing
- City
- La Vergne
- State
- TN
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 96151
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Address 1
- 341 Mason Rd
- Address 2
- N/A
- Postal code
- 37086-3606
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide U.S. and Puerto rico
- Recall number
- D-0226-2025
- Product quantity
- 82,281 cartons
- Recall initiation date
- 20250121
- Center classification date
- 20250219
- Report date
- 20250226
- Product description
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61
- 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.
- Code info
Lot #s: N01424, N01425, Exp 03/31/2025; N01659, N01660, Exp 08/31/2025; N01668, 09/2025; N01679, N01704, N01745, Exp 10/31/2025; N01856, Exp 02/28/2026; N01973, Exp 05/31/2026; N02079, Exp 08/31/2026.