HI-LITE Cream recalled over sterility concerns

Recall date

February 10, 2017

Source

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

Official notice title

Synergy Rx recalls HI-LITE Cream (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A…

Recall number

D-0560-2017

FDA classification

Class II

Brand / firm

Synergy Rx

Sold / distributed

Nationwide within the United States

Why it was recalled

Lack of Assurance of Sterility: There are also CGMP Deviations.

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

What was recalled

HI-LITE Cream (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676