FDA-Drug2019-10-09Class II

OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676819

KRS Global Biotechnology, Inc
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide
Affected count
4497 bags
Manufactured in
791 Park of Commerce Blvd Ste 600, N/A, Boca Raton, FL, United States
Products
OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676819

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0083-2020

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