FDA recall D-0290-2015

Fresenius Kabi USA, LLC · Class II · drug

Product

GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20

Reason for recall

Defective Container: Vials may be missing stoppers.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2014-11-12
Report date: 2014-12-17
Termination date: 2016-03-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Melrose Park, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0290-2015