Recalls / Class II
Class IID-0530-2023
Product
Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10
- Brand name
- Pantoprazole Sodium
- Generic name
- Pantoprazole
- Active ingredient
- Pantoprazole Sodium
- Route
- Oral
- NDCs
- 31722-712, 31722-713
- FDA application
- ANDA202882
- Affected lot / code info
- Lot #: PAN22542, Exp. Date: 9/2024
Why it was recalled
CGMP Deviations: Discoloration
Recalling firm
- Firm
- Hetero USA Inc
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- N/A
- Address
- 1035 Centennial Ave, N/A, Piscataway, New Jersey 08854-4124
Distribution
- Quantity
- 2,352 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-03-14
- FDA classified
- 2023-04-11
- Posted by FDA
- 2023-04-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0530-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.