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.
Reported: February 13, 2013 Initiated: November 8, 2012 #D-154-2013
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.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 31,326 vials
- Distribution
- Nationwide and Puerto Rico.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hospira Inc.. Units affected: 31,326 vials.
Why was this product recalled? ▼
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 13, 2013. Severity: Critical. Recall number: D-154-2013.
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