Reported Aug 22, 2012 · Terminated
Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL…
Hospira Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hospira Inc. · 275 N Field Dr · Lake Forest, IL · 60045-2579
Is this the product you have?
- 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
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 lot number Y031654AB, expiration APR2013; NDC 61703-360-18 (Novoplus label) 2 lot number Y031654AA, expiration APR2013; 45 mL vial - NDC 61703-339-50 (Hospira label) 3 lot numbers Y041711AA, expiration DEC 2012 and Y061711AB, expiration FEB 2013; NDC 61703-360-50 (Novoplus label) 4 lot number Y061711AA, expiration FEB 2013 - Amount recalled
- 77,542 vials
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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