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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 Pyridoxine HCL (B6) Injection Recalled for Sterility Concerns

Agency Publication Date: September 20, 2024
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Summary

Empower Pharmacy has recalled 450 units of Pyridoxine HCL (B6) Injection Solution (100mg/mL, 30 mL vials) due to a lack of assurance of sterility. This compounded medication is an injectable vitamin supplement intended for intramuscular or intravenous use. Using an injection that is not properly sterile can lead to severe or life-threatening infections. These products were distributed nationwide directly to healthcare practitioners and facilities.

Risk

A lack of sterility assurance means the medication could be contaminated with microorganisms. If injected, these contaminants can cause serious infections, including sepsis or meningitis, which may be life-threatening.

What You Should Do

  1. This recall affects Pyridoxine HCL (B6) Injection Solution, 100mg/mL, in 30 mL sterile multiple-dose vials, compounded by Empower Pharmacy (NDC 72627-2424-1).
  2. Check your supply for lot number 609763 with a Beyond Use Date of 04/18/2025.
  3. Stop using the recalled product immediately. Contact Empower Pharmacy or your distributor to arrange for the return of any remaining vials.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Product return and quarantine

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Pyridoxine HCL (B6) Injection Solution (30 mL)
Variants: 100mg/mL, Sterile Multiple-Dose Vial, For IM or IV use only, RX Only
Lot Numbers:
609763 (Beyond Use Date 04/18/2025)
NDC:
72627-2424-1

Compounded by Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95304
Status: Resolved
Manufacturer: Empower Pharmacy
Sold By: Healthcare facilities; Healthcare practitioners
Manufactured In: United States
Units Affected: 450
Distributed To: Nationwide

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.