LIPO W/LIDOCAINE #3 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 W/LIDOCAINE #3 W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;D3-30MG; B5-5MG;B6-5MG;CYANO B12-…

Recall number

D-1201-2016

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 W/LIDOCAINE #3 W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;D3-30MG; B5-5MG;B6-5MG;CYANO B12-1MG; METHIONINE 12.5MG; INOSITOL-25MG; CHOLINE CL-25 MG; LIDOCAINE 10MG/ML, In a) 5 ML Vials and b) 10ML Vials, MEDAUS PHARMACY