D-154-2013 Class I Terminated
FDA drug recall D-154-2013 was initiated by Hospira Inc. on Nov 8, 2012 and is designated Class I. Reason for recall: Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. The recall status is terminated (terminated Oct 15, 2026). Affected quantity: 31,326 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 13, 2013
- Initiation Date
- Nov 8, 2012
- Termination Date
- Oct 15, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,326 vials
Product Description
Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Hospira label) and NDC 61703-360-50 (Novaplus label), Hospira, Inc., Lake Forest, IL 60045, Product of Australia.
Reason for Recall
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Distribution Pattern
Nationwide and Puerto Rico.
Code Information
lots Z011711AA (Hospira label) and Z011711AB (Novaplus label), Exp. 08/2013
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-154-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026