D-1648-2012 Class III Terminated
FDA drug recall D-1648-2012 was initiated by Hospira Inc. on Jul 2, 2012 and is designated Class III. Reason for recall: Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH. The recall status is terminated (terminated Jul 24, 2017). Affected quantity: 77,542 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 22, 2012
- Initiation Date
- Jul 2, 2012
- Termination Date
- Jul 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 77,542 vials
Product Description
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1648-2012
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026