Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister c...
FDA Recall #D-0622-2024 — Class I — July 10, 2024
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.
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.
Recalling Firm
Endo Pharmaceuticals, Inc. — Malvern, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
8,139 cartons
Distribution
Nationwide in the USA and Puerto Rico
Code Information
Lot 550147301, Exp. 08/31/2026
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated