Drug recall D-0297-2015

Class II Terminated reported Dec 17, 2014

Product

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.

Lots and codes

Lot 6003853, exp. date 04/2014

Recall details

Recalling firm
Fresenius Kabi USA, LLC, Lake Zurich, IL
Quantity
240,550 Vials
Distribution
U.S. Nationwide Including Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
September 27, 2012
Terminated
December 12, 2014

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