FDAClass IIFebruary 19, 2020

Amoxicillin and Clavulanate Potassium Tablets recall

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

Why was Amoxicillin and Clavulanate Potassium Tablets recalled?

Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: SM8719040-A, Exp. Date 02/2021

Product
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
Recalling firm
AuroMedics Pharma LLC
Quantity
30432 bottles
Distribution
Nationwide within the United States
Recall date
February 19, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls