Class II Recall

Hetero Labs Limited (Unit V)

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
Reason
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Classification
Class II
Status
Ongoing
Lot
Batch # FD253967, Exp Date: 06/26/2027
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Hetero Labs Limited (Unit V) — Class II Recall | MedicineWatch US