Drug product
Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
D-0097-2022
Product summary
- Event
- Event 88862
- Status
- Terminated
- Classification
- Class II
- Quantity
- 335 vials
- Official record key
drug-enforcement:D-0097-2022
Official wording
Reason: Lack of assurance of sterility
Code information: Lot: 04122021:51 BUD: 10/09/2021; 04232021:94 BUD: 10/20/2021; 05032021:52 BUD: 10/30/2021; 05242021:73 BUD: 11/20/2021; 05172021:47 BUD: 11/13/2021; 06302021:93 BUD: 12/27/2021; 06222021:98 BUD: 12/19/2021; 06072021:83 BUD: 12/04/2021; 07152021:86 BUD: 01/11/2022; 07222021:52 BUD: 01/18/2022; 08062021:11 BUD: 02/02/2022; 08192021:73 BUD: 02/15/2022; 08312021:22 BUD: 02/27/2022; 09162021:58 03/15/2022; 09082021:15 BUD: 03/07/2022
Distribution pattern: United States including Washington, D.C. and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility