Drug recall D-1648-2012
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
Reason for recall
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Lots and codes
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
Recall details
- Recalling firm
- Hospira Inc., Lake Forest, IL
- Quantity
- 77,542 vials
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 2, 2012
- Terminated
- July 24, 2017
Related products
- Carboplatin – drug information
- NDC 61703-360 Carboplatin · Carboplatin 10 mg/mL · Hospira, Inc.
- NDC 61703-600 Carboplatin · Carboplatin 10 mg/mL · Hospira, Inc.
- NDC 61703-150 Carboplatin · Carboplatin 10 mg/mL · Hospira, Inc.
- NDC 61703-339 Carboplatin · Carboplatin 10 mg/mL · Hospira, Inc.
- NDC 61703-262 Carboplatin · Carboplatin 10 mg/mL · Hospira, Inc.