PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 19, 2020 Initiated: February 7, 2020 #D-0852-2020

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

Reason for Recall

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

Details

Recalling Firm
AuroMedics Pharma LLC
Units Affected
30432 bottles
Distribution
Nationwide within the United States
Location
East Windsor, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by AuroMedics Pharma LLC. Units affected: 30432 bottles.
Why was this product recalled?
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Which agency issued this recall?
This recall was issued by the FDA Drug on February 19, 2020. Severity: Moderate. Recall number: D-0852-2020.