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Recall Observatory FDA recall evidence

Drug 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.

D-0297-2015

September 27, 2012

Class II

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 63451
Status
Terminated
Classification
Class II
Quantity
240,550 Vials
Official record key
drug-enforcement:D-0297-2015

Official wording

Reason: Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

Code information: Lot 6003853, exp. date 04/2014

Distribution pattern: U.S. Nationwide Including Puerto Rico

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    glass particles
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility