Acid Reducer Capsule, Delayed Release
FDA Recall NDC 70000-0232
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Acid Reducer (NDC 70000-0232). A significant event, classified as Class II, was initiated on Oct 05, 2021 by Leader/ Cardinal Health 110, Inc.. The reported reason for this action was: "CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Oct 05, 2021
Oct 27, 2021
8,976 bottles
Recall Profile & Regulatory Data
Event ID
88809
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Dec 06, 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
Batch or Lot Expiration Information
Lot# BT001594C
Affected Packages Involved in this Recall
70000-0232-1Product
70000-0232-2Product
70000-0232-3Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
