Amlodipine And Olmesartan Medoxomil Tablet, Film Coated
FDA Recall NDC 65862-855
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 Amlodipine And Olmesartan Medoxomil (NDC 65862-855). A significant event, classified as Class III, was initiated on Nov 30, 2018 by Aurobindo Pharma Limited. The reported reason for this action was: "Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach)."
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
Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
Nov 30, 2018
Dec 12, 2018
4464 bottles
Recall Profile & Regulatory Data
Event ID
81703
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Feb 01, 2022
Product Description
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30
Batch or Lot Expiration Information
Lot# : OWSA18002-A, Exp 7/2020
Affected Packages Involved in this Recall
65862-854-30Product
65862-855-30Product
65862-856-30Product
65862-857-30Product
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.
