FDA-Drug2019-10-09Class II
Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine Mesylate-30 mg / Atropine Sulfate Monohydrate-0.375 mg / Vial) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678398
KRS Global Biotechnology, Inc
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide
Affected count
91 vials
Manufactured in
791 Park of Commerce Blvd Ste 600, N/A, Boca Raton, FL, United States
Products
Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine Mesylate-30 mg / Atropine Sulfate Monohydrate-0.375 mg / Vial) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678398
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0091-2020Don't want to check this manually?
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