Drug & medication recalls Moderate risk

Estriol USP41 Micro 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 Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Ph…
Recall number
D-0695-2021
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

Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01

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