Recalls / Class II
Class IID-0194-2024
Product
Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 69238-2078-1
- Brand name
- Propranolol Hydrochloride
- Generic name
- Propranolol Hydrochloride
- Active ingredient
- Propranolol Hydrochloride
- Route
- Oral
- NDCs
- 69238-2077, 69238-2078, 69238-2079, 69238-2080, 69238-2081
- FDA application
- ANDA071972
- Affected lot / code info
- Batch 100023596
Why it was recalled
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recalling firm
- Firm
- CARDINAL HEALTHCARE
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7200 Cardinal Pl W, Dublin, Ohio 43017-1094
Distribution
- Quantity
- 2 units
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2022-01-26
- FDA classified
- 2023-12-26
- Posted by FDA
- 2024-01-03
- Terminated
- 2024-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0194-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.