FDA Drug recall D-0263-2020
S-ESTRADIOL VALERATE 40MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX
- FDA Drug
- Class II
- terminated
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class II recall of S-ESTRADIOL VALERATE 40MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX by First Royal Care, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0263-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-12 |
| Published | 2019-11-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | First Royal Care |
| Distribution | US |
Product
S-ESTRADIOL VALERATE 40MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX.
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot# S06062019DH@03, Exp 9/6/19; S06182019DH@01, Exp 9/18/19 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0263-2020%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.