ERBITUX 770 MG/ IVPB recalled over sterility concerns
- Recall date
- June 12, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Infusion Options, Inc. recalls ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ 425 ml IVPB, Rx Only, Infusion Options, Inc.…
- Recall number
- D-1774-2019
- FDA classification
- Class II
- Brand / firm
- Infusion Options, Inc.
- Sold / distributed
- NY only
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ 425 ml IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
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