TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800
FDA Recall #D-0772-2020 — Class II — December 20, 2019
Product Description
TESTOSTERONE CYP 200MG/ML OIL 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
166 vials
Distribution
Nationwide within the United States
Code Information
Lots: 09122019@9 Exp. 03/10/2020; 09242019@9 Exp. 03/22/2020; 09192019@20 Exp. 03/17/2020; 10032019@8 Exp. 03/31/2020; 10032019@11 Exp. 03/31/2020; 10182019@5 Exp. 04/15/2020; 10242019@7 Exp. 04/21/2020; 10232019@24 Exp. 04/20/2020; 11042019@12 Exp. 05/02/2020; 11212019@3 Exp. 05/19/2020; 11212019@2 Exp. 05/19/2020; 11042019@15 Exp. 05/02/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.