Recalls / Class II
Class IID-013-2014
Product
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03
- Brand name
- Ondansetron
- Generic name
- Ondansetron
- Active ingredient
- Ondansetron Hydrochloride
- Route
- Intramuscular, Intravenous
- NDCs
- 0409-4755, 0409-4759
- FDA application
- ANDA077548
- Affected lot / code info
- 29-484-DK* and 29-510-DK* Exp 05/01/2015 (lot number may be proceeded with an 01)
Why it was recalled
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 681,400 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-09-24
- FDA classified
- 2013-11-20
- Posted by FDA
- 2013-11-27
- Terminated
- 2014-10-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-013-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.