Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), Fo...
FDA Recall #D-0199-2018 — Class II — November 16, 2017
Product Description
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.
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
94 vials
Distribution
Nationwide in the USA, Bermuda, and New Zealand
Code Information
Lot: 06142017@6 BUD: 12/11/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated