October 2021 FDA Recall Acid Reducer by Dr. Reddy's Laboratories, Inc.
D-0026-2022 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on October 5, 2021 for the product Acid Reducer. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0026-2022
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
10-05-2021
10-27-2021
8,976 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
12-06-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# BT001594C
