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Recall Observatory FDA recall evidence

Drug product

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.

D-0420-2025

May 02, 2025

Class II

Product summary

Firm
Empower Clinic Services, LLC dba Empower Pharmacy
Event
Event 96808
Status
Ongoing
Classification
Class II
Quantity
8,230 vials
Official record key
drug-enforcement:D-0420-2025

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 202364, Exp 5/28/2025

Distribution pattern: USA Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility