Status
Completed
Drug Enforcement D-154-2013
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Classification
Class I
Report Date
February 13, 2013
Termination Date
March 20, 2017
Product Information
- 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.
- Product quantity
- 31,326 vials
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico.
Location & Firm
- Recalling firm
- Hospira Inc.
- Address
-
275 N Field Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-154-2013
- Event ID
- 63548
- Recall initiation date
- November 8, 2012
- Center classification date
- February 6, 2013
- Code info
- lots Z011711AA (Hospira label) and Z011711AB (Novaplus label), Exp. 08/2013
- More code info
- —