FDA recall D-0263-2020
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy · Class II · drug
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 for recall
Lack of Assurance of Sterility
Distribution
Nationwide in the USA
Key facts
- Status
- Terminated
- Initiation date
- 2019-08-12
- Report date
- 2019-11-13
- Termination date
- 2023-04-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Mesa, AZ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0263-2020