D-0026-2022 Class II Terminated

Recalled by Dr. Reddy's Laboratories, Inc. — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
October 27, 2021
Initiation Date
October 5, 2021
Termination Date
December 6, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,976 bottles

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.

Distribution Pattern

Nationwide in the USA

Code Information

BT001594C