Drug & medication recalls Moderate risk

Azelaic Acid 99 recalled over manufacturing violations

Recall date
July 15, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
API Solutions Inc. recalls Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals…
Recall number
D-0696-2021
FDA classification
Class II
Brand / firm
API Solutions Inc.
Sold / distributed
AL, AZ, CO, FL, VA

Why it was recalled

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

Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals Corp. China Distributed by: Syntec Pharma Corp New York

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