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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Empower Pharmacy Estradiol Cypionate Injection Recalled for Sterility Concerns

Agency Publication Date: August 8, 2024
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Summary

Empower Clinic Services LLC has voluntarily recalled approximately 2,797 vials of Empower Pharmacy Estradiol Cypionate Injection (10mg/mL, 5mL Sterile Multiple Dose Vial). The recall was initiated because of a lack of assurance of sterility for the affected lot. Using a medication that is not sterile can lead to serious, potentially life-threatening infections at the site of injection or within the bloodstream.

Risk

A lack of assurance of sterility means the product may be contaminated with bacteria or other microorganisms. Injecting a non-sterile product can cause severe infections, particularly in patients with compromised immune systems.

What You Should Do

  1. This recall affects approximately 2,797 vials of Empower Pharmacy Estradiol Cypionate Injection (10mg/mL, 5mL Sterile Multiple Dose Vial). Affected products are labeled with lot number 179338 and a beyond-use date of 08/14/2024.
  2. If you have health concerns related to the use of this medication, contact your healthcare provider or pharmacist immediately.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Empower Clinic Services LLC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information or to report any adverse events.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Empower Pharmacy Estradiol Cypionate Injection
Variants: 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only
Lot Numbers:
179338 (Beyond use date: 08/14/2024)

Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95079
Status: Resolved
Manufacturer: EMPOWER CLINIC SERVICES LLC
Sold By: Empower Pharmacy
Manufactured In: United States
Units Affected: 2,797
Distributed To: Nationwide
Agency Last Updated: August 12, 2024

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.