Lipoplex recalled over sterility concerns

Recall date

April 8, 2019

Source

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

Official notice title

Customceutical Compounding recalls Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG…

Recall number

D-1257-2019

FDA classification

Class II

Brand / firm

Customceutical Compounding

Sold / distributed

U.S.A. Nationwide

Why it was recalled

Lack of assurance of sterility for injectables and solutions intended to be sterile.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/ML PYRIDOXINE HCL 50 MG/ML), 10 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272