Recalls / Class I
Class ID-154-2013
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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.
- Brand name
- Carboplatin
- Generic name
- Carboplatin
- Active ingredient
- Carboplatin
- Route
- Intravenous
- NDC
- 61703-339
- FDA application
- ANDA076517
- Affected lot / code info
- lots Z011711AA (Hospira label) and Z011711AB (Novaplus label), Exp. 08/2013
Why it was recalled
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 31,326 vials
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2012-11-08
- FDA classified
- 2013-02-06
- Posted by FDA
- 2013-02-13
- Terminated
- 2017-03-20
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-154-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.