Endo Pharmaceuticals, Inc.: Drug Recall

Recall #D-0622-2024 · 07/10/2024

Class I: Dangerous

Recall Details

Recall Number: D-0622-2024
Classification: Class I
Product Type: Drug
Recalling Firm: Endo Pharmaceuticals, Inc.
Status: Terminated
Date Initiated: 07/10/2024
Location: Malvern, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8,139 cartons

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.

Distribution Pattern

Nationwide in the USA and Puerto Rico

Other Recalls by Endo Pharmaceuticals, Inc.

Class II: Risk 03/02/2023

Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.

View all recalls by Endo Pharmaceuticals, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.