Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1 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 Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, R…
- Recall number
- D-0115-2020
- 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
Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678335
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