Class I
Terminated
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.
This recall has been terminated (originally issued August 7, 2024).
- Company
- Endo Pharmaceuticals, Inc.
- Recall Initiated
- July 10, 2024
- Posted
- August 7, 2024
- Recall Number
- D-0622-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,139 cartons
- Firm Location
- Malvern, PA, United States
- Official Source
- View on FDA website ↗
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
Nationwide in the USA and Puerto Rico
Lot / Code Info
Lot 550147301, Exp. 08/31/2026
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