CLOBETASOL 0 recalled over sterility concerns

Recall date

February 10, 2017

Source

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

Official notice title

Synergy Rx recalls CLOBETASOL 0.05% IN OLEA BASE, CLOBETASOL 0.05% IN OROBASE, CLOBETASOL 0.05% OINTMENT, CLOBETASOL 0.05%/ SODIUM, SULFAC…

Recall number

D-0535-2017

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

CLOBETASOL 0.05% IN OLEA BASE, CLOBETASOL 0.05% IN OROBASE, CLOBETASOL 0.05% OINTMENT, CLOBETASOL 0.05%/ SODIUM, SULFACETAMIDE 10% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676