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.

Recall Number: D-0295-2015

Firm: Fresenius Kabi USA, LLC

Classification: Class II

Status: Terminated

Report Date: 20141217

Initiation Date: 20120927

Termination Date: 20141212

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

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.