Recalls / Class III
Class IIID-1386-2019
Product
Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
- Brand name
- Ondansetron
- Generic name
- Ondansetron Hydrochloride
- Active ingredient
- Ondansetron Hydrochloride
- Route
- Intramuscular, Intravenous
- NDCs
- 63323-373, 63323-374
- FDA application
- ANDA076972
- Affected lot / code info
- Lot #: 6018699, Exp. 12/2021
Why it was recalled
Failed Impurities/Degradation Specifications.
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3159 Staley Rd, N/A, Grand Island, New York 14072-2028
Distribution
- Quantity
- 11,981 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-05-22
- FDA classified
- 2019-06-14
- Posted by FDA
- 2019-06-19
- Terminated
- 2021-01-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1386-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.