Recall: D-0456-2017

Class II - Potentially Harmful

Class IIClassification

2016-12-16Initiated

TerminatedStatus

Fresenius Kabi USA, LLCFirm

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

Reason

Failed Impurities/Degradation Specifications

Distribution

Nationwide and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.