5% Dextrose Injection USP recalled over sterility concerns
- Recall date
- March 25, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- B. Braun Medical Inc recalls 5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, N…
- Recall number
- D-0094-2017
- FDA classification
- Class I
- Brand / firm
- B. Braun Medical Inc
- Sold / distributed
- Nationwide
Why it was recalled
Non-Sterility: fungal contamination due to leaking containers.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32
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