Recalls / Class II
Class IID-0178-2022
Product
TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected lot / code info
- Lot: T1006042021:60 BUD: 12/01/2021; T1008302021:63 BUD: 02/26/2022; T1005122021:36 BUD: 11/08/2021; T1007142021:23 BUD: 01/10/2022; T1008192021:94 BUD: 02/15/2022; 04202021:80 BUD: 10/17/2021; T1007012021:31 BUD: 12/28/2021; T1009092021:97 BUD: 03/08/2022; T1004092021:79 BUD: 10/06/2021; T1005242021:08 BUD: 11/20/2021; T1008092021:82 BUD: 02/05/2022; T1005042021:92 BUD: 10/31/2021; T1007262021:03 BUD: 01/22/2022; T1006172021:47 BUD: 12/14/2021
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
- 334 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-0178-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.