Drug recall D-0622-2024

Class I Terminated reported Aug 7, 2024

Product

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.

Reason for recall

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.

Lots and codes

Lot 550147301, Exp. 08/31/2026

Recall details

Recalling firm
Endo Pharmaceuticals, Inc., Malvern, PA
Quantity
8,139 cartons
Distribution
Nationwide in the USA and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
July 10, 2024
Terminated
September 16, 2025

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