D-0622-2024 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 7, 2024
- Initiation Date
- July 10, 2024
- Termination Date
- September 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