FDA Recall D-0622-2024
Endo Pharmaceuticals, Inc. · Malvern, PA
Class I — life-threatening Terminated 433 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-0622-2024- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall initiated
- 2024-07-10
- Classified by FDA Center
- 2024-07-30
- FDA published
- 2024-08-07
- Terminated
- 2025-09-16
- Recalling firm
- Endo Pharmaceuticals, Inc.
- Firm location
- Malvern, PA
Drug identification
- Brand name(s)
- CLONAZEPAM
- Generic name(s)
- CLONAZEPAM
- Manufacturer(s)
- Par Health USA, LLC
- NDC(s)
49884-306, 49884-307, 49884-308, 49884-309, 49884-310- Route(s)
- ORAL