TRICHLOROACETIC ACID SOLUTION in all strengths including: 10% recalled over sterility concerns

Recall date

February 10, 2017

Source

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

Official notice title

Synergy Rx recalls TRICHLOROACETIC ACID SOLUTION in all strengths including: 10%, 12%, 15 %, 20%, 35%, 70%, and 85%, TRICHLOROCETIC ACID 1…

Recall number

D-0544-2017

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

TRICHLOROACETIC ACID SOLUTION in all strengths including: 10%, 12%, 15 %, 20%, 35%, 70%, and 85%, TRICHLOROCETIC ACID 10%/ LACTIC ACID 12%, TRICHLOROCETIC ACID 6%/LACTIC ACID 12%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676