SALICYLIC ACID SOLUTION in all strengths including 20% recalled over sterility concerns

Recall date

February 10, 2017

Source

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

Official notice title

Synergy Rx recalls SALICYLIC ACID SOLUTION in all strengths including 20%, 25%, 30%, and 40%, SALICYCLIC ACID 20%. 2.5%5-FU, SALICYCLIC AC…

Recall number

D-0543-2017

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

SALICYLIC ACID SOLUTION in all strengths including 20%, 25%, 30%, and 40%, SALICYCLIC ACID 20%. 2.5%5-FU, SALICYCLIC ACID 20%, 5-FU 2.5% CREAM, SALICYCLIC ACID 20%/5-FU 2.5% MEDICATION STICK, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676