Pantoprazole Sodium Delayed Release Tablets USP 40mg recalled over manufacturing violations

Recall date

March 14, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Hetero USA Inc recalls Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuti…

Recall number

D-0530-2023

FDA classification

Class II

Brand / firm

Hetero USA Inc

Sold / distributed

Nationwide within the United States

Why it was recalled

CGMP Deviations: Discoloration

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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