S-ESTRADIOL CYP 5MG/ML MDV INJ IN ETHYL OLEATE — Class II drug recall D-0218-2020
Terminated recall by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy, reported 2019-11-13, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0218-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy, Mesa, AZ, United States |
| Recall initiated | 2019-08-12 |
| Classified | 2019-11-05 |
| Reported by FDA | 2019-11-13 |
| Terminated | 2023-04-13 |
| Distributed | Nationwide (US) |
| Quantity | 11 |
| Reason classes | sterility |
| Expiration dates | 2019-08-09, 2019-09-11, 2019-10-22 |
Product
S-ESTRADIOL CYP 5MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10 ml, glass vials, Rx Only, Red Mountain Compounding RX
Reason for recall
Lack of Assurance of Sterility
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-0218-2020. 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.