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FDAFDA · Food and drugs·Recall number D-0622-2024

Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.

Published August 7, 2024 · Recall initiated: July 10, 2024

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
CLONAZEPAM
Manufacturer
Endo Pharmaceuticals, Inc.
Distributor
Nationwide in the USA and Puerto Rico
Lot
Lot 550147301, Exp. 08/31/2026
Risk classification
Class I
Area (FDA)
drug
Country
United States

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