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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

People's Custom Rx C-Progesterone Oil Recalled for Lack of Sterility

Agency Publication Date: August 9, 2021
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Summary

People's Custom Rx is recalling 14 vials of C-Progesterone Oil (progesterone) 100 mg/mL, 10 mL vials. The recall was issued because the compounded drug may lack sterility. No incidents or injuries have been reported to date regarding this product, which was distributed in Mississippi and Tennessee. If you have any of this medication, you should consult with a healthcare professional or pharmacist.

Risk

Injecting a product that is not sterile can lead to serious health issues, ranging from localized infections at the injection site to life-threatening systemic infections.

What You Should Do

  1. The recalled product is People's Custom Rx C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, labeled with lot number 11649 and a Beyond Use Date (BUD) of 07/07/2021.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: C-PROGESTERONE OIL (100 MG/ML)by People's Custom Rx
Variants: 10 mL vials, Compounded
Lot Numbers:
11649 (Exp 07/07/2021)

Recall #: D-0718-2021; Quantity: 14 vials

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88340
Status: Resolved
Manufacturer: People's Custom Rx and Clinical Care, LLC
Sold By: People's Custom Rx
Manufactured In: United States
Units Affected: 14 vials
Distributed To: Mississippi, Tennessee

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.