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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