KRS Global Biotechnology, Inc recalls Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5
Recalled January 17, 2018 · FDA recall D-0199-2018 · KRS Global Biotechnology
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. · FDA Class II
Units
94 vials
Sold at
Nationwide in the USA, Bermuda, and New Zealand
Description
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.
Product
Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Manufacturer(s)
KRS Global Biotechnology, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →