FDA-Drug2018-01-17Class II
Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
KRS Global Biotechnology, Inc
Hazard
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Sold states
Nationwide in the USA, Bermuda, and New Zealand
Affected count
235 vials
Manufactured in
791 Park of Commerce Blvd Ste 600, N/A, Boca Raton, FL, United States
Products
Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0198-2018Don't want to check this manually?
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