Drug 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
D-0530-2023
Product summary
- Firm
- Hetero USA Inc
- Event
- Event 91855
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,352 bottles
- Official record key
drug-enforcement:D-0530-2023
Official wording
Reason: CGMP Deviations: Discoloration
Code information: Lot #: PAN22542, Exp. Date: 9/2024
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations