FDA recall D-0456-2017

Fresenius Kabi USA, LLC · Class II · drug

Product

MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2016-12-16
Report date: 2017-02-08
Termination date: 2018-06-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0456-2017