Reported Feb 26, 2025 · Ongoing
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 341 Mason Rd · La Vergne, TN · 37086-3606
Is this the product you have?
- 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 byMajor Pharmaceuticals, Indianapolis, IN 26268 USA
- NDC0904-6008-61
- Lot codes and dates
10 of 10 products
Products covered by this recall # Product as published 1 N01419, N01420, N01421, Exp 03/31/2025 2 N01663, Exp 06/30/2025 3 N01664, Exp 08/31/2025 4 N01673, Exp 09/30/2025 5 N01688, Exp 08/31/2025 6 N01747, N01748, N01749, Exp 11/30/2025 7 N01792, Exp 12/31/2025 8 N01857, Exp 02/28/2026 9 N01974, Exp 05/31/2026 10 N02081, Exp 08/31/2026. - Amount recalled
- 94,349 cartons
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
This product could cause temporary or reversible health problems — stop using it.
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