FDA-Drug2019-10-09Class II

fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216282300

KRS Global Biotechnology, Inc
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide
Affected count
492 bags
Manufactured in
791 Park of Commerce Blvd Ste 600, N/A, Boca Raton, FL, United States
Products
fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216282300

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0049-2020

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