Recalls / Class II
Class IID-0180-2022
Product
TESTOSTERONE CYPIONATE 200MG/ML INJ #2 IN SESAME OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected lot / code info
- Lot: T1007082021:20 BUD: 01/04/2022; T0907262021:21 BUD: 01/04/2022; T0506142021:81 BUD: 12/11/2021; T104142021:49 BUD: 10/11/2021; T1006022021:96 BUD: 11/29/2021; T0507152021:79 BUD: 01/11/2022; T1009082021:42 BUD: 03/07/2022; T0508172021:37 BUD: 02/13/2022; T0505112021:57 BUD: 10/11/2021
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
- 43 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-0180-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.