Recalls / Class I
Class ID-0622-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Brand name
- Clonazepam
- Generic name
- Clonazepam
- Active ingredient
- Clonazepam
- Route
- Oral
- NDCs
- 49884-306, 49884-307, 49884-308, 49884-309, 49884-310
- FDA application
- ANDA077171
- Affected lot / code info
- Lot 550147301, Exp. 08/31/2026
Why it was recalled
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.
Recalling firm
- Firm
- Endo Pharmaceuticals, Inc.
- Manufacturer
- Par Health USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1400 Atwater Dr, N/A, Malvern, Pennsylvania 19355-8701
Distribution
- Quantity
- 8,139 cartons
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2024-07-10
- FDA classified
- 2024-07-30
- Posted by FDA
- 2024-08-07
- Terminated
- 2025-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0622-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.