D-0263-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 13, 2019
- Initiation Date
- August 12, 2019
- Termination Date
- April 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 5ml and 10 ml glass vials
Product Description
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 Pattern
Nationwide in the USA
Code Information
Lot# S06062019DH@03, Exp 9/6/19; S06182019DH@01, Exp 9/18/19