TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800
FDA Recall #D-0771-2020 — Class II — December 20, 2019
Product Description
TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800
Reason for Recall
Lack of sterility assurance.
Recalling Firm
Assurance Infusion — Houston, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
7 vials
Distribution
Nationwide within the United States
Code Information
Lots: 08212019@17 Exp. 02/17/2020; 10232019@23 Exp. 04/20/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated