Recalls / Class II
Class IID-0169-2022
Product
TESTOSTERONE CYPIONATE 100MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected lot / code info
- Lot: T0204272021:49 BUD: 10/24/2021; T0206142021:55 BUD: 12/11/2021; T0209082021:74 BUD: 03/07/2022; T0506212021:52 BUD: 12/18/2021; T0207082021:41 BUD: 01/04/2022; T0208112021:07 BUD: 02/07/2022; T0206012021:26 BUD: 11/28/2021; T0507122021:00 BUD: 01/08/2022; T0505112021:58 BUD: 11/07/2021; T0205182021:56 BUD: 11/14/2021; T0506102021:88 BUD: 12/07/2021; T0508182021:56 BUD: 02/14/2022
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
- 168 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-0169-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.