FDA recall D-0868-2017

Product

Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20

Reason for recall

Subpotent Drug; Clavulanic Acid

Distribution

NY, OH

Key facts

Status

Terminated

Initiation date

2017-04-26

Report date

2017-06-07

Termination date

2019-08-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0868-2017