Home / Recalls / Hetero USA Inc / D-0530-2023

D-0530-2023 Class II Ongoing

Recalled by Hetero USA Inc — Piscataway, NJ

Recall Details

Product Type
Drugs
Report Date
April 19, 2023
Initiation Date
March 14, 2023
Termination Date
N/A
Voluntary/Mandated
N/A
Product Quantity
2,352 bottles

Product Description

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 for Recall

CGMP Deviations: Discoloration

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: PAN22542, Exp. Date: 9/2024

Other recalls by Hetero USA Inc

  • D-1095-2017 Class II — Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: C (July 20, 2017)
  • D-0897-2017 Class III — Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Cam (April 27, 2017)
  • D-0623-2017 Class III — Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: C (January 7, 2017)