Olmesartan Medoxomil Tablet, Coated
FDA Recall NDC 67877-445
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Olmesartan Medoxomil (NDC 67877-445). A significant event, classified as Class III, was initiated on Apr 29, 2021 by Ascend Laboratories, Llc. The reported reason for this action was: "Presence of Foreign Tablet/Capsule"
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 III Terminated
Presence of Foreign Tablet/Capsule
Apr 29, 2021
Jun 02, 2021
34296 bottles
Recall Profile & Regulatory Data
Event ID
87817
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 17, 2023
Product Description
Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.
Batch or Lot Expiration Information
Batch# Batch No. 20122548, Exp Date: Aug. 2022
Affected Packages Involved in this Recall
67877-445-30Product
67877-445-90Product
67877-445-05Product
67877-445-10Product
67877-446-30Product
67877-446-90Product
67877-446-05Product
67877-446-10Product
67877-446-33Product
67877-446-84Product
67877-446-74Product
67877-446-38Product
67877-447-30Product
67877-447-90Product
67877-447-05Product
67877-447-10Product
January 2020 Class II Recall: cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Recall Number
Class II Terminated
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Jan 24, 2020
Feb 12, 2020
192 Bottles
Recall Profile & Regulatory Data
Event ID
84818
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Oct 29, 2021
Product Description
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.
Batch or Lot Expiration Information
Lot# : 19122552, Exp 7/31/2021
Affected Packages Involved in this Recall
67877-445-30Product
67877-445-90Product
67877-445-05Product
67877-445-10Product
67877-446-30Product
67877-446-90Product
67877-446-05Product
67877-446-10Product
67877-446-33Product
67877-446-84Product
67877-446-74Product
67877-446-38Product
67877-447-30Product
67877-447-90Product
67877-447-05Product
67877-447-10Product
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.
