FDA Drug Recalls

Recalls / Class II

Class IID-0159-2022

Product

TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Affected lot / code info
Lot: T1007072021:98 BUD: 01/03/2022; T1005252021:31 BUD: 11/21/2021; T1009222021:60 BUD: 03/21/2022

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
13 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-0159-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.