Warning
Hetero Labs Limited (Unit V) Recalls Pantoprazole Sodium
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0484-2026Drug / Pharmaceutical
Hetero Labs Limited (Unit V) Recalls Pantoprazole Sodium
Hetero Labs Limited (Unit V) · Class II — Moderate Risk
Product Description
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 for Recall
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide in the USA.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database