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Drug FDA Class II Terminated Contamination / non-sterility

Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.

Empower Pharmacy Published Oct 2, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Empower Pharmacy or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility

Hazards

Lack of Assurance of Sterility · primary

Affected products (1)

Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.

450

Lot codes: number
Code info: Product lot number: 609763 Beyond Use Date: 04/18/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Sep 5, 2024
  2. Published
    Oct 2, 2024
  3. Terminated
    Feb 14, 2025
Recall number
D-0663-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.