Hospira Inc.: 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

Is my product affected?

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).

• Brand MITOXANTRONE

Check against the official notice below — it lists the full affected range.

What happened

Hospira Inc. is recalling MitoXANTRONE Injection, USP (concentrate) 2 mg/mL due to failed stability specifications. The affected product is subpotent and contains out-of-specification known and unknown impurities. The recall involves 13,792 vials distributed nationwide in the United States and Puerto Rico, as well as in Australia, Canada, Cyprus, Egypt, Ireland, Saudi Arabia, Qatar, Oman, Bahrain, and the United Kingdom.

The recalled lots in the United States are: Lot Z054636AA (expiring December 2014), Lot A014636AA (expiring April 2015), Lot A024636AB (expiring July 2015), Lot A014645AA (expiring November 2015), and Lot A014643AA (expiring April 2015). The source document does not specify what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities. Distribution: US: Nationwide including Puerto Rico; Australia, Canada, Cyprus, Egypt, Ireland, Saudi Arabia, Qatar, Oman, Bahrain, and United Kingdom. Quantity: 13,792 Vials (U.S.) Lot/code info: 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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