FDA-Drug2019-10-09Class II

Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676632

KRS Global Biotechnology, Inc
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide
Affected count
1980 vials
Manufactured in
791 Park of Commerce Blvd Ste 600, N/A, Boca Raton, FL, United States
Products
Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676632

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0052-2020

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