RecallRadar

FDA Drug recall D-0695-2021

Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT b…

On 2021-08-04 the FDA classified a Class II recall of Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT b… by Api Solutions, citing cGMP Deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0695-2021
ClassificationClass II
Statusterminated
Initiated2021-07-15
Published2021-08-04
Last updated2026-09-13 11:52 UTC
CompanyApi Solutions
DistributionAL, AZ, CO, FL, VA

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

cGMP Deviations

Identifiers

code_infoLot #: ETL181001, Exp 10/09/2021

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0695-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.