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Home Prescription medicine The Harvard Drug Group LLC dba Major…

Food & drug recall · FDAJanuary 21, 2025Serious

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 in this package is from NDC # 69315-90

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

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

The Recall Registry rates this seriousFDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

The product

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.

Details

Units affected
27,525 cartons
Recall date
January 21, 2025
Brand
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Model, lot or SKU numbers
Lot #s: N01422, N01423, Exp 03/31/2025N01661, N01662, Exp 09/30/2025N01746, N01750, Exp 10/31/2025N01876, N01877, Exp 03/31/2026N01899, N01900, N01975, Exp 04/30/2026.
Where it was distributed

Nationwide U.S. and Puerto rico

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: 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 in this package is from NDC # 69315-90

Read it on FDA

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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