FDA recall D-0852-2020

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

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2020-02-07

Report date

2020-02-19

Termination date

2022-11-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0852-2020