Omeprazole Capsule, Delayed Release
FDA Recall NDC 62175-118
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 Omeprazole (NDC 62175-118). A significant event, classified as Class II, was initiated on Sep 16, 2013 by Lannett Company, Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance."
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
Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
Sep 16, 2013
Nov 27, 2013
3867 bottles
Recall Profile & Regulatory Data
Event ID
66218
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Kremers Urban Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
KY & TN
Termination Date
May 09, 2014
Product Description
Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43
Batch or Lot Expiration Information
Lot# Lot Number 59627; Expiration Date 02/2014
Affected Packages Involved in this Recall
62175-114-37Product
62175-114-32Product
62175-114-46Product
62175-114-49Product
62175-118-49Product
62175-118-32Product
62175-118-46Product
62175-118-37Product
62175-118-43Product
62175-136-32Product
62175-136-46Product
62175-136-37Product
62175-136-43Product
62175-136-49Product
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.
