Class I
Ongoing
Clonazepam Orally Disintegrating Tablets, USP, 0.25 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#: 49884-307-02 (carton), NDC #: 49884-307-52 (blisters).
This recall is currently active, issued January 15, 2025. It was issued by Endo Usa, Inc..
- Company
- Endo Usa, Inc.
- Recall Initiated
- November 18, 2024
- Posted
- January 15, 2025
- Recall Number
- D-0180-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 72,973 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. The blister strips inside the product carton reflect the correct strength.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #s: 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, 550147401, Exp. 08/31/2026.
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