Biotin Solution for Injection recalled over sterility concerns

Recall date

November 17, 2021

Source

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

Official notice title

ASP CARES recalls Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2…

Recall number

D-0261-2022

FDA classification

Class II

Brand / firm

ASP CARES

Sold / distributed

United States

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

Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-0589-30