D-0622-2024 Class I Terminated
FDA drug recall D-0622-2024 was initiated by Endo Pharmaceuticals, Inc. on Jul 10, 2024 and is designated Class I. 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. The recall status is terminated (terminated Sep 16, 2025). Affected quantity: 8,139 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 7, 2024
- Initiation Date
- Jul 10, 2024
- Termination Date
- Sep 16, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,139 cartons
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot 550147301, Exp. 08/31/2026