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Recall Observatory FDA recall evidence

Drug product

Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064

D-0630-2024

August 02, 2024

Class II

Product summary

Firm
EMPOWER CLINIC SERVICES LLC
Event
Event 95079
Status
Terminated
Classification
Class II
Quantity
2,797
Official record key
drug-enforcement:D-0630-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 179338, Beyond use date: 08/14/2024

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility