Pyridoxine HCL Injection Solution recalled over sterility concerns

Recall date

September 5, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Empower Pharmacy recalls Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Com…

Recall number

D-0663-2024

FDA classification

Class II

Brand / firm

Empower Pharmacy

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.