FDA recall D-0026-2022

Dr. Reddy's Laboratories, Inc. · Class II · drug

Product

Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1

Reason for recall

CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2021-10-05
Report date: 2021-10-27
Termination date: 2022-12-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0026-2022