BevaDex Prefilled Syringes recalled over sterility concerns
- Recall date
- August 15, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Bella Pharmaceuticals, Inc. recalls BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, I…
- Recall number
- D-1161-2017
- FDA classification
- Class II
- Brand / firm
- Bella Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide within USA
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
BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA.
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