Recalls / Class III
Class IIID-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
- Brand name
- Carboplatin
- Generic name
- Carboplatin
- Active ingredient
- Carboplatin
- Route
- Intravenous
- NDCs
- 61703-339, 61703-150, 61703-360, 61703-262, 61703-600
- FDA application
- ANDA076517
- Affected 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
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.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 77,542 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2012-07-02
- FDA classified
- 2012-08-16
- Posted by FDA
- 2012-08-22
- Terminated
- 2017-07-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1648-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.