Hospira Inc. recalls Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL mul
Recalled August 22, 2012 · FDA recall D-1648-2012 · Hospira
Hazard
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH. · FDA Class III
Units
77,542 vials
Sold at
Nationwide and Puerto Rico
Description
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Product
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
Manufacturer(s)
Hospira Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →