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  3. Recall Enforcement Event ID: 62459

Recall Enforment Report D-1679-2012

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Hospira Inc., originally initiated on 06-27-2012 for the product 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) The product was recalled due to 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.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1679-201206-27-201209-26-2012Class II30,582 vialsCarboplatin 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)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.Terminated
D-1680-201206-27-201209-26-2012Class II210 vialsCytarabine 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 61703-303-46The 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.Terminated
D-1682-201206-27-201209-26-2012Class II131,264 vialsPaclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; N DC 61703-342-50The 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.Terminated
D-1681-201206-27-201209-26-2012Class II34,572 vialsMethotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-408-41The 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.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
61703-015Paclitaxel PaclitaxelInjection, SolutionIntravenousHospira, Inc.Human Prescription Drug
61703-303Cytarabine CytarabineInjection, SolutionIntravenousHospira, Inc.Human Prescription Drug
61703-339Carboplatin CarboplatinInjection, SolutionIntravenousHospira, Inc.Human Prescription Drug
61703-342Paclitaxel PaclitaxelInjection, SolutionIntravenousHospira, Inc.Human Prescription Drug
61703-350Methotrexate MethotrexateInjection, SolutionIntramuscular; Intravenous; SubcutaneousHospira, Inc.Human Prescription Drug
61703-350Methotrexate MethotrexateInjection, SolutionIntramuscular; Intravenous; SubcutaneousHospira, Inc.Human Prescription Drug
61703-408Methotrexate MethotrexateInjection, SolutionIntramuscular; Intrathecal; Intravenous; SubcutaneousHospira, Inc.Human Prescription Drug
61703-408Methotrexate MethotrexateInjection, SolutionIntramuscular; Intrathecal; Intravenous; SubcutaneousHospira, Inc.Human Prescription Drug