FDA recall D-0695-2021

Product

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

Distribution

AL, AZ, CO, FL, VA

Key facts

Status

Terminated

Initiation date

2021-07-15

Report date

2021-08-04

Termination date

2022-02-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Daphne, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0695-2021