Recalls / Class II
Class IID-0506-2021
Product
Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA
- Brand name
- Pantoprazole Sodium
- Generic name
- Pantoprazole Sodium
- Active ingredient
- Pantoprazole Sodium
- Route
- Oral
- NDCs
- 62175-617, 62175-180, 62175-618
- FDA application
- ANDA078281
- Affected lot / code info
- 20249489A
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Lannett Company, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 4 bottles
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0506-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.