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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

Pharm D Solutions, LLC: Human Chorionic Gonadotropin Recalled for Lack of Sterility Assurance

Agency Publication Date: December 20, 2018
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Summary

Pharm D Solutions, LLC is recalling 85 vials of Human Chorionic Gonadotropin (hCG) 3000 IU, an injectable prescription hormone medication. The recall was initiated because the company's manufacturing processes and equipment could not guarantee that the products were sterile. Using a non-sterile injectable drug can lead to serious health consequences, including localized or systemic infections. These products were distributed in Washington state and are identified by the Pharm D. Solutions brand on the label.

Risk

Injecting a product that is not guaranteed to be sterile can introduce bacteria or other contaminants directly into the body, potentially causing life-threatening infections or abscesses. While no specific injuries have been reported, the inadequate equipment used during production means the safety of the medication cannot be confirmed.

What You Should Do

  1. Check your medication vials for Human Chorionic Gonadotropin 3000 IU with the Pharm D. Solutions brand name and the following identifiers: Lot 10292018:21 (also listed as Lot 10292018) and an expiration date of 3/31/2019.
  2. Immediately stop using any affected vials of this medication and do not inject the product.
  3. Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any potential adverse reactions.
  4. Return any unused vials to the pharmacy where you purchased them for a refund and contact Pharm D Solutions, LLC at 1-844-263-6843 for further instructions.
  5. If you have additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Human Chorionic Gonadotropin 3000 IU
Model:
NDC: 69699-1738-10
Recall #: D-0343-2019
Lot Numbers:
10292018:21 (Exp. 3/31/2019)
10292018
Date Ranges: Expiration Date: 3/31/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81629
Status: Resolved
Manufacturer: Pharm D Solutions, LLC
Sold By: Pharm D Solutions, LLC
Manufactured In: United States
Units Affected: 85 vials
Distributed To: Washington

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 · 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.