← FDA ENFORCEMENT
D-0622-2024Class I

Endo Pharmaceuticals, Inc.

Recalling firm
Endo Pharmaceuticals, Inc.
Product type
Drug
Status
Terminated
Report date
2024-08-07
Distribution
Nationwide in the USA and Puerto Rico
Firm state
PA
Product quantity
8,139 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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.

Product description

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.

Code / lot info

Lot 550147301, Exp. 08/31/2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.