FDA Drug recall D-0919-2017
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 Prescri…
- FDA Drug
- Class II
- terminated
- Published 2017-06-21
On 2017-06-21 the FDA classified a Class II recall of 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 Prescri… by American Pharmaceutical Ingredients, citing cGMP Deviations; lack of quality assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0919-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-17 |
| Published | 2017-06-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | American Pharmaceutical Ingredients |
| Distribution | CA, GA, KY, NV, NY, TX |
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
cGMP Deviations; lack of quality assurance.
Identifiers
| code_info | Lots: 052915-1, 052915-2, exp 5/5/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0919-2017%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.