LIPO-INJECTION W/LIDOCAINE 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-INJECTION W/LIDOCAINE (PF), ASCORBIC ACID 50MG; B1-50MG; B2-5-PO4-5MG; B3-50MG B5-5MG, B6-5MG, CYANO B-12-100MCG,…

Recall number

D-1203-2016

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-INJECTION W/LIDOCAINE (PF), ASCORBIC ACID 50MG; B1-50MG; B2-5-PO4-5MG; B3-50MG B5-5MG, B6-5MG, CYANO B-12-100MCG, METHIONINE 12.5 MG, INOSITOL 25 MG, CHOLINE CL-25 MG, LIDCAINE 10 MG/ML, 2ML Vials, MEDAUS PHARMACY