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Class II · ModerateRecall completed

Amoxicillin And Clavulanate Potassium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: SM8719040-A, Exp. Date 02/2021
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAurobindo Pharma Limited
Brand nameAMOXICILLIN AND CLAVULANATE POTASSIUM
Generic nameAMOXICILLIN AND CLAVULANATE POTASSIUM
Active ingredient(s)AMOXICILLIN, CLAVULANATE POTASSIUM
Distributed by / forAurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520
NDC65862-503-20
Show the full FDA record
Full product labelAmoxicillin 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 firmAuroMedics Pharma LLC
DistributionNationwide within the United States
Quantity30432 bottles
Recall initiated2020-02-07
Report date2020-02-19
Recall completed2022-11-17
Recall numberD-0852-2020
ClassificationClass II
FDA statusTerminated
Origin on fileEast Windsor NJ United States

Related

Amoxicillin recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.