FDA Recall D-0433-2015

Hospira Inc. · Lake Forest, IL

Class I — life-threatening Terminated 730 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 61703-343-65); c) 30 mg/15 mL Multi Dose Vial (NDC: 61703-343-66).

Lot / code: LOTS DISTRIBUTED IN THE UNITED STATES: a) Lot: Z054636AA, Expiry: December 2014; Lot: A014636AA, Expiry: April 2015; Lot: A024636AB, Expiry: July 2015. b) Lot: A014645AA, Expiry: November 2015. c) Lot: A014643AA, Expiry April 2015.

Quantity: 13,792 Vials (U.S.)

Reason for recall

Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.

Recall record

Recall number: D-0433-2015
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US: Nationwide including Puerto Rico; Australia, Canada, Cyprus, Egypt, Ireland, Saudi Arabia, Qatar, Oman, Bahrain, and United Kingdom.
Recall initiated: 2014-12-03
Classified by FDA Center: 2015-04-06
FDA published: 2015-04-15
Terminated: 2016-12-02
Recalling firm: Hospira Inc.
Firm location: Lake Forest, IL

Drug identification

Brand name(s): MITOXANTRONE
Generic name(s): MITOXANTRONE
Manufacturer(s): Hospira, Inc.
NDC(s): 61703-343
Route(s): INTRAVENOUS

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