PlainRecalls
FDA Drug Moderate Class II Terminated

S-ESTRADIOL VALERATE 20MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX.

Reported: November 13, 2019 Initiated: August 12, 2019 #D-0219-2020

Product Description

S-ESTRADIOL VALERATE 20MG/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

Details

Units Affected
2x5ml, 1x10 ml glass vials
Distribution
Nationwide in the USA
Location
Mesa, AZ

Frequently Asked Questions

What product was recalled?
S-ESTRADIOL VALERATE 20MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX.. Recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy. Units affected: 2x5ml, 1x10 ml glass vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on November 13, 2019. Severity: Moderate. Recall number: D-0219-2020.