B-Complex + Chromic Chloride recalled over sterility concerns

Recall date

May 24, 2022

Source

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

Official notice title

US Specialty Formulations LLC recalls B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chl…

Recall number

D-0987-2022

FDA classification

Class II

Brand / firm

US Specialty Formulations LLC

Sold / distributed

Product was distributed to medical facilities and a physician's office Nationwide in the USA.

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

B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty Formulations, LLC, 116 Research Drive, Bethlehem, PA 18015, P/N: 234-15523