MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP P...
FDA Recall #D-0295-2015 — Class II — September 27, 2012
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
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
101,200 Vials
Distribution
U.S. Nationwide Including Puerto Rico
Code Information
Lot 6003827, Exp. Date 04/2015
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated