Amoxicillin And Clavulanate Potassium Tablet, Film Coated
FDA Recall NDC 0781-1874
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 0781-1874). A significant event, classified as Class III, was initiated on Apr 26, 2017 by Sandoz Inc. The reported reason for this action was: "Subpotent Drug; Clavulanic Acid"
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
Subpotent Drug; Clavulanic Acid
Apr 26, 2017
Jun 07, 2017
4,464 bottles
Recall Profile & Regulatory Data
Event ID
77117
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sandoz Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NY, OH
Termination Date
Aug 19, 2019
Product Description
Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20
Batch or Lot Expiration Information
Lot# Lot FP8735, 8/2017
Affected Packages Involved in this Recall
0781-1874-31Product
0781-1831-20Product
0781-1831-13Product
0781-1831-01Product
0781-1852-20Product
0781-1852-13Product
0781-1852-01Product
0781-6102-46Product
0781-6102-57Product
0781-6102-52Product
0781-6104-46Product
0781-6104-57Product
0781-6104-52Product
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.
