Estrone — Class II drug recall D-0792-2017
Terminated recall by Fagron, Inc, reported 2017-05-31, distributed nationwide. cGMP Deviations: lack of quality assurance at the API manufacturer.
| Recall number | D-0792-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fagron, Inc, Saint Paul, MN, United States |
| Recall initiated | 2017-04-06 |
| Classified | 2017-05-19 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2019-07-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 1,313 grams |
| Reason classes | cgmp |
| NDC | 51552-0445-01, 51552-0445-02, 51552-0445-04, 51552-0445-05, 52372-9494-01, 52372-9494-02, 52372-9494-03, 52372-9494-05 |
| Expiration dates | 2018-05-17, 2018-05-18 |
Product
Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estrone USP, For Prescription Compounding, packaged in a) 1 G bottle (NDC 52372-9494-01), b) 5 G bottle (NDC 52372-9494-05), c) 25 G bottle (NDC 52372-9494-03), d) 100 G bottle ( NDC 52372-9494-02), Rx only, Distributed by FREEDOM 801 W. New Orleans St. Broken Arrow, OK 74011 Tel. (877) 839-8547
Reason for recall
cGMP Deviations: lack of quality assurance at the API manufacturer.
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-0792-2017. 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.