Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-50 (Hospira label), NDC 61703-360-50 (Novoplus label)
Check against the official notice below — it lists the full affected range.
Hospira Inc. is recalling multiple lots of Carboplatin Injection and related chemotherapy medications (Cytarabine Injection, Methotrexate Injection, and Paclitaxel Injection) distributed nationwide and internationally due to visible particles embedded in the glass at the neck of the vials. The particles may become dislodged into the medication solution if the product comes into contact with them. Approximately 30,582 vials across multiple lot numbers with expiration dates ranging from February 2013 to November 2013 are affected.
The recall impacts distribution in the United States, Puerto Rico, Guam, and numerous international locations including Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand, and Vietnam. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig 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.
Reason for recall: The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig 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. Distribution: 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 Quantity: 30,582 vials Lot/code info: lot numbers Y061711AA, exp FEB 2013 and Y061711AB, exp FEB 2013 rest of world lots being recalled: list M1685A001, lots numbers Y151686AB, exp MAY 2013 and Y131686AA, exp MAR 2013; list M1723A001, lot number Y121686AF, exp SEP 2013; list M1686ADE1, lot numbers Y121686AA, exp SEP 2013 and Y151686AC, exp NOV 2013; list M1686AFR1, lot numbers Y121686AG, exp SEP 2013 and Y131686AB, exp SEP 2013; list M1714A001, lot number Y121686AC, exp SEP 2013; list M1686ANO3, lot number Y121686AE, exp SEP 2013; list M1686ASE2, lot number Y121686AB, exp SEP 2013
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.