Amoxicillin And Clavulanate Potassium Tablet, Film Coated
FDA Recall NDC 65862-503
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 Amoxicillin And Clavulanate Potassium (NDC 65862-503). A significant event, classified as Class II, was initiated on Feb 07, 2020 by Aurobindo Pharma Limited. The reported reason for this action was: "Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie"
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
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Feb 07, 2020
Feb 19, 2020
30432 bottles
Recall Profile & Regulatory Data
Event ID
84910
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Nov 17, 2022
Product Description
Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20
Batch or Lot Expiration Information
Lot# : SM8719040-A, Exp. Date 02/2021
Affected Packages Involved in this Recall
65862-501-30Product
65862-501-05Product
65862-502-20Product
65862-502-05Product
65862-503-20Product
65862-503-01Product
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.
