Fresenius Kabi USA, LLC recalls Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive,…
- Recall date
- June 4, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1234-2015
- FDA classification
- Class II
- Brand / firm
- Fresenius Kabi USA, LLC
- Sold / distributed
- Nationwide,Hawaii, and Puerto Rico
Why it was recalled
Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20
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