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Recall Observatory FDA recall evidence

Drug product

Cytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-303-46

D-1680-2012

June 27, 2012

Class II

Product summary

Firm
Hospira Inc.
Event
Event 62459
Status
Terminated
Classification
Class II
Quantity
210 vials
Official record key
drug-enforcement:D-1680-2012

Official wording

Reason: The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.

Code information: lot numbers Y131994AA, exp AUG 2013; Y141994AA, exp SEP 2013; Y151994AA, exp SEP 2013; Y161994AA, exp NOV 2013; Y171994AA, exp NOV 2013 and Y181994AA, exp NOV 2013

Distribution pattern: Nationwide, including Puerto Rico and Guam. Product was also distributed internationally to Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand and Vietnam

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    visible particles