LIPO-BOOST 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-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-52MG, METHYL, B12-500MCG, CARNITINE 50…

Recall number

D-1205-2016

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-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-52MG, METHYL, B12-500MCG, CARNITINE 50 MG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE 30MG/ML, In a) 3ML Vials and b) 5ML Vials, MEDAUS PHARMACY