FDAClass IINovember 13, 2019

S-estradiol Valerate 20mg/ml MDV INJ in Ethyl Oleate recall: Sterility Concern

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

Why was S-estradiol Valerate 20mg/ml MDV INJ in Ethyl Oleate recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: S07232019DH@10, Exp 10/23/19; S08012019DH@03, Exp 11/1/19;

Product
S-ESTRADIOL VALERATE 20MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX.
Recalling firm
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Quantity
2x5ml, 1x10 ml glass vials
Distribution
Nationwide in the USA
Recall date
November 13, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls