Home / Recalls / Hospira Inc. / D-1679-2012

D-1679-2012 Class II Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA drug recall D-1679-2012 was initiated by Hospira Inc. on Jun 27, 2012 and is designated Class II. 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… The recall status is terminated (terminated Dec 15, 2016). Affected quantity: 30,582 vials.

Recall Details

Product Type: Drugs
Report Date: Sep 26, 2012
Initiation Date: Jun 27, 2012
Termination Date: Dec 15, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 30,582 vials

Product Description

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)

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 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

Code Information

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1679-2012
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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