Fresenius Kabi USA, LLC recalls MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Sc
Recalled December 17, 2014 · FDA recall D-0295-2015 · Fresenius Kabi USA
Hazard
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. · FDA Class II
Units
101,200 Vials
Sold at
U.S. Nationwide Including Puerto Rico
Description
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
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.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →