ESTRADIOL VALERATE 40MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, ...
FDA Recall #D-0112-2022 — Class II — October 12, 2021
Product Description
ESTRADIOL VALERATE 40MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Reason for Recall
Lack of assurance of sterility
Recalling Firm
Vita Pharmacy, LLC dba Talon Compounding Pharmacy — San Antonio, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
11 vials
Distribution
United States including Washington, D.C. and Puerto Rico
Code Information
Lot: 09082021:11 BUD: 03/07/2022; 07022021:66 BUD: 12/29/2021; 05202021:46 BUD: 11/16/2021; 08192021:24 BUD: 02/15/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated