TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800

FDA Recall #D-0770-2020 — Class II — December 20, 2019

Recall #D-0770-2020 Date: December 20, 2019 Classification: Class II Status: Terminated

Product Description

TESTOSTERONE CYP 200MG/ML OIL 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

5 vials

Distribution

Nationwide within the United States

Code Information

Lot: 10242019@7 Exp. 04/21/2020; 10032019@11 Exp. 03/31/2020; 11042019@12 Exp. 05/02/2020; 09242019@9 Exp. 03/22/2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated