PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: October 27, 2021 Initiated: October 5, 2021 #D-0026-2022

Product Description

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.

Details

Units Affected
8,976 bottles
Distribution
Nationwide in the USA
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 8,976 bottles.
Why was this product recalled?
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 27, 2021. Severity: Moderate. Recall number: D-0026-2022.