ESTRONE — Class II drug recall D-0664-2017
Terminated recall by Medisca, Inc., reported 2017-04-19, distributed nationwide. cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA ins
| Recall number | D-0664-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medisca, Inc., Plattsburgh, NY, United States |
| Recall initiated | 2017-04-03 |
| Classified | 2017-04-12 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2019-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BS, GB, IT, SG, TH |
| Reason classes | cgmp |
| NDC | 38779-0891-03, 38779-0891-04, 38779-0891-05, 38779-0891-06, 38779-0891-09 |
Product
ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891
Reason for recall
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
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-0664-2017. 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.