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Recall Observatory FDA recall evidence

Drug 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.

D-0622-2024

July 10, 2024

Class I

Product summary

Firm
Endo Pharmaceuticals, Inc.
Event
Event 94945
Status
Terminated
Classification
Class I
Quantity
8,139 cartons
Official record key
drug-enforcement:D-0622-2024

Official wording

Reason: 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.

Code information: Lot 550147301, Exp. 08/31/2026

Distribution pattern: Nationwide in the USA and Puerto Rico

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Error