Recall: D-0530-2023

Class II - Potentially Harmful

Class IIClassification

2023-03-14Initiated

OngoingStatus

Hetero USA IncFirm

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

Reason

CGMP Deviations: Discoloration

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (N/A). If you take this product, talk to your pharmacist or doctor before stopping it.