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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

The Compounding Pharmacy of America: HCG and Methylcobalamin Injection Recalled for Non-Sterility

Agency Publication Date: February 11, 2018
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Summary

The Compounding Pharmacy of America has recalled 5 vials of HCG (human chorionic gonadotropin) 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection in 5 mL multi-dose vials. This recall was initiated because the product was found to be non-sterile, which means it may contain harmful microorganisms. The medication was distributed to patients in Tennessee and South Carolina, and using a non-sterile injectable product can lead to severe health complications. If you have this product, you should contact your healthcare provider or pharmacist immediately.

Risk

Injectable medications that are not sterile can introduce bacteria or fungi directly into the body, potentially causing serious, life-threatening infections or localized reactions at the injection site.

What You Should Do

  1. Check your medication label to see if you have 'HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL' compounded by The Compounding Pharmacy of America.
  2. Identify if your product is from Lot 01052018@46 with a Use By date of 2/9/2018.
  3. Stop using the affected medication immediately if it matches the lot number and expiration date listed above.
  4. Contact your healthcare provider or pharmacist for guidance on your treatment and to report any side effects.
  5. Return any unused vials to the pharmacy for a refund and contact The Compounding Pharmacy of America at (855) 277-2488 for further instructions.
  6. For 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

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection (5 mL)
Model:
Recall #: D-0600-2018
Lot Numbers:
01052018@46 (Use By: 2/9/2018)
01052018
Date Ranges: Use By: 2/9/2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79168
Status: Resolved
Manufacturer: The Compounding Pharmacy of America
Sold By: The Compounding Pharmacy of America
Manufactured In: United States
Units Affected: 5 vials
Distributed To: Tennessee, South Carolina

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.