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Fresenius Kabi USA, LLC recalls MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Sc

Recalled February 8, 2017 · FDA recall D-0456-2017 · Fresenius Kabi USA

Hazard
Failed Impurities/Degradation Specifications · FDA Class II
Units
47, 020 vials
Sold at
Nationwide and Puerto Rico

Description

Failed Impurities/Degradation Specifications

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
Manufacturer(s)
Fresenius Kabi USA, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Fresenius Kabi USA, LLC recalls MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Sc | RecallWatchUSA