FDA Recall D-153-2013
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Completed 1593 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-56.
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 record
- Recall number
D-153-2013- Classification
- Class I
- Status
- Completed
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide and Puerto Rico.
- Recall initiated
- 2012-11-08
- Classified by FDA Center
- 2013-02-06
- FDA published
- 2013-02-13
- Terminated
- 2017-03-20
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL
Drug identification
- Brand name(s)
- CARBOPLATIN
- Generic name(s)
- CARBOPLATIN
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
61703-339- Route(s)
- INTRAVENOUS