FDA recall D-0295-2015

Fresenius Kabi USA, LLC · Class II · drug

Product

MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.

Reason for recall

Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

Distribution

U.S. Nationwide Including Puerto Rico

Key facts

Status: Terminated
Initiation date: 2012-09-27
Report date: 2014-12-17
Termination date: 2014-12-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0295-2015