LIPO B CYANO 1MG/ML W/PRES recalled over sterility concerns

Recall date

May 13, 2016

Source

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

Official notice title

Medaus, Inc. recalls LIPO B CYANO 1MG/ML W/PRES. (BENZYL ETOH 1%) METHIONINE 25MG, INOSITOL 50MG, CHOLINE CHL-50MG, CYANO B-12-100MCG, BENZY…

Recall number

D-1204-2016

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

LIPO B CYANO 1MG/ML W/PRES. (BENZYL ETOH 1%) METHIONINE 25MG, INOSITOL 50MG, CHOLINE CHL-50MG, CYANO B-12-100MCG, BENZYL ALCOHOL 1%/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY