Recall: D-0026-2022

Class II - Potentially Harmful

Class IIClassification

2021-10-05Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.