Reported Feb 19, 2020 · Terminated

Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma…

AuroMedics Pharma LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: AuroMedics Pharma LLC · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401

Is this the product you have?

  • Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles
  • Distributed byAurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20
Lot codes and dates
    • Lot #: SM8719040-A
    • Exp. Date 02/2021
Amount recalled
30432 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 17, 2022 · Data as of Sep 19, 7:51 PM UTC

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