D-0179-2025 Class I Ongoing

Recalled by Endo USA, Inc. — Malvern, PA

Recall Details

Product Type
Drugs
Report Date
January 15, 2025
Initiation Date
November 18, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,029 cartons

Product Description

Clonazepam Orally Disintegrating Tablets, USP, 0.125 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#: 49884-306-02 (carton), NDC #: 49884-306-52 (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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 550174101, Exp. 01/31/2027.