Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Comp...
FDA Recall #D-0420-2025 — Class II — May 2, 2025
Product Description
Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-8577, Compounding Date: 08/20/2024, Beyond Use by Date: 05/28/2025, Lot 202364.
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
Empower Clinic Services, LLC dba Empower Pharmacy — Houston, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
8,230 vials
Distribution
USA Nationwide
Code Information
Lot #: 202364, Exp 5/28/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated