Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blis...
FDA Recall #D-0178-2025 — Class I — November 18, 2024
Product Description
Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters).
Reason for Recall
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Recalling Firm
Endo USA, Inc. — Malvern, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
9,816 cartons
Distribution
Nationwide in the USA
Code Information
Lot # 550176501, 550176601, Exp 02/28/2027.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated