Estriol USP41 Micro 25 Grams — Class II drug recall D-0695-2021
Terminated recall by API Solutions Inc., reported 2021-08-04, distributed in AL, AZ, CO, FL, VA. cGMP Deviations
| Recall number | D-0695-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | API Solutions Inc., Daphne, AL, United States |
| Recall initiated | 2021-07-15 |
| Classified | 2021-07-28 |
| Reported by FDA | 2021-08-04 |
| Terminated | 2022-02-08 |
| Distributed | AL, AZ, CO, FL, VA |
| Quantity | 20 bottles |
| Reason classes | cgmp |
| NDC | 46144-0300-01 |
| Lot numbers | ETL181001 |
| Expiration dates | 2021-10-09 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0695-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.