CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. ...
FDA Recall #D-0297-2015 — Class II — September 27, 2012
Product Description
CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-044-01.
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
240,550 Vials
Distribution
U.S. Nationwide Including Puerto Rico
Code Information
Lot 6003853, exp. date 04/2014
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated