Recalls / Class II
Class IID-0097-2022
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
- Affected lot / code info
- 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
Why it was recalled
Lack of assurance of sterility
Recalling firm
- Firm
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 2950 Thousand Oaks Dr Ste 25, N/A, San Antonio, Texas 78247-3347
Distribution
- Quantity
- 335 vials
- Distribution pattern
- United States including Washington, D.C. and Puerto Rico
Timeline
- Recall initiated
- 2021-10-12
- FDA classified
- 2021-11-08
- Posted by FDA
- 2021-11-17
- Terminated
- 2023-10-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0097-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.