ESTRONE USP — Class II drug recall D-0919-2017
Terminated recall by American Pharmaceutical Ingredients LLC, reported 2017-06-21, distributed in CA, GA, KY, NV, NY, TX. cGMP Deviations; lack of quality assurance.
| Recall number | D-0919-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Pharmaceutical Ingredients LLC, Waterford, MI, United States |
| Recall initiated | 2017-04-17 |
| Classified | 2017-06-15 |
| Reported by FDA | 2017-06-21 |
| Terminated | 2018-05-31 |
| Distributed | CA, GA, KY, NV, NY, TX |
| Reason classes | cgmp |
| NDC | 58597-8049-02, 58597-8049-03, 58597-8049-04 |
| Lot numbers | 052915-1, 052915-2 |
| Expiration dates | 2017-05-05 |
Product
ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327
Reason for recall
cGMP Deviations; lack of quality assurance.
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-0919-2017. 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.