Drug product
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10
D-0484-2026
Product summary
- Event
- Event 98671
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,740 1,000-count bottles.
- Official record key
drug-enforcement:D-0484-2026
Official wording
Reason: Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Code information: Batch # FD253967, Exp Date: 06/26/2027
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Unknown
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."