FDA-Drug2023-04-19Class II

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

Hetero USA Inc
Hazard

CGMP Deviations: Discoloration

Sold states
Nationwide within the United States
Affected count
2,352 bottles
Manufactured in
1035 Centennial Ave, N/A, Piscataway, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0530-2023

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