FDA-Drug2014-12-17Class II
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.
Fresenius Kabi USA, LLC
Hazard
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Sold states
U.S. Nationwide Including Puerto Rico
Affected count
101,200 Vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0295-2015Don't want to check this manually?
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