RecallDepth
Class III Terminated

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

Company
Hospira Inc.
Recall Initiated
July 2, 2012
Posted
August 22, 2012
Recall Number
D-1648-2012
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
77,542 vials
Firm Location
Lake Forest, IL, United States

Reason for Recall

Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.

Distribution

Nationwide and Puerto Rico

Lot / Code Info

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

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