MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP ...
FDA Recall #D-0456-2017 — Class II — December 16, 2016
Product Description
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 for Recall
Failed Impurities/Degradation Specifications
Recalling Firm
Fresenius Kabi USA, LLC — Lake Zurich, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
47, 020 vials
Distribution
Nationwide and Puerto Rico
Code Information
Lot 6007327, exp. 01-2017; Lot 6007329, exp. 01-2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated