Bacteriostatic Water for Injection recalled over sterility concerns
- Recall date
- September 12, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- KRS Global Biotechnology, Inc recalls Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton,…
- Recall number
- D-0042-2020
- FDA classification
- Class II
- Brand / firm
- KRS Global Biotechnology, Inc
- Sold / distributed
- Nationwide
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
Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177
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