Product: T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For Intracavernouse Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Reason for recall: 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.
Recall initiated: 20171116
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated