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 S…

Recall date

December 16, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0456-2017

FDA classification

Class II

Brand / firm

Fresenius Kabi USA, LLC

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Failed Impurities/Degradation Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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