Carboplatin Injection, Solution
FDA Recall NDC 61703-600
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Carboplatin (NDC 61703-600). A significant event, classified as Class III, was initiated on Jul 02, 2012 by Hospira, Inc.. The reported reason for this action was: "Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Jul 02, 2012
Aug 22, 2012
77,542 vials
Recall Profile & Regulatory Data
Event ID
62463
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jul 24, 2017
Product Description
Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL multi-dose vials (NDC 61703-339-50) (NDC 61703-360-50 NOVAPLUS), Rx only, Hospira, Inc., Lake Forest, IL 60045, Product of Australia
Batch or Lot Expiration Information
Lot# 5 mL vial - NDC 61703-339-18 (Hospira label), lot number Y031654AB, expiration APR2013; NDC 61703-360-18 (Novoplus label), lot number Y031654AA, expiration APR2013; 45 mL vial - NDC 61703-339-50 (Hospira label), lot numbers Y041711AA, expiration DEC 2012 and Y061711AB, expiration FEB 2013; NDC 61703-360-50 (Novoplus label), lot number Y061711AA, expiration FEB 2013
Affected Packages Involved in this Recall
61703-339-18Product
61703-339-22Product
61703-339-50Product
61703-339-56Product
61703-360-18Product
61703-150-05Product
61703-262-05Product
61703-600-05Product
61703-360-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
