Recalls / Class II
Class IID-0184-2025
Product
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21
- Brand name
- Clobazam
- Generic name
- Clobazam
- Active ingredient
- Clobazam
- Route
- Oral
- NDC
- 60687-423
- FDA application
- ANDA209718
- Affected lot / code info
- Lot #: 1019594, Exp. Date 12/31/2025
Why it was recalled
Presence of Foreign Tablets/Capsules
Recalling firm
- Firm
- Amerisource Health Services LLC
- Manufacturer
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 5,178 cartons
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-12-13
- FDA classified
- 2025-01-06
- Posted by FDA
- 2025-01-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0184-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.