FDA recall D-0530-2023

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 for recall

CGMP Deviations: Discoloration

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2023-03-14

Report date

2023-04-19

Voluntary/Mandated

N/A

Location

Piscataway, NJ, United States

Primary source

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