Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For I...
FDA Recall #D-0198-2018 — Class II — November 16, 2017
Product Description
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.
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.
Recalling Firm
KRS Global Biotechnology, Inc — Boca Raton, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
235 vials
Distribution
Nationwide in the USA, Bermuda, and New Zealand
Code Information
Lot: 05262017@21 BUD: 11/22/2017; 07132017@2 BUD: 1/9/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated