Medaus product recalled over sterility concerns

Recall date

May 13, 2016

Source

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

Official notice title

Medaus, Inc. recalls M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG,…

Recall number

D-1222-2016

FDA classification

Class II

Brand / firm

Medaus, Inc.

Sold / distributed

U.S. Nationwide, Japan, and New Zealand.

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

M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG, B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG, METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML Vials, MEDAUS PHARMACY