PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 4, 2021 Initiated: July 15, 2021 #D-0695-2021

Product Description

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

Reason for Recall

cGMP Deviations

Details

Recalling Firm
API Solutions Inc.
Units Affected
20 bottles
Distribution
AL, AZ, CO, FL, VA
Location
Daphne, AL

Frequently Asked Questions

What product 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. Recalled by API Solutions Inc.. Units affected: 20 bottles.
Why was this product recalled?
cGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on August 4, 2021. Severity: Moderate. Recall number: D-0695-2021.