Fresenius Kabi USA, LLC recalls Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 633…
- Recall date
- May 22, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1386-2019
- FDA classification
- Class III
- Brand / firm
- Fresenius Kabi USA, LLC
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Failed Impurities/Degradation Specifications.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
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