Recalls / Class II
Class IID-0165-2022
Product
TEST CYPIONATE 200MG/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: T1006042021:53 BUD: 12/01/2021; T1008192021:83 BUD: 02/15/2022; T1005212021:52 BUD: 11/17/2021; T1009072021:35 BUD: 03/06/2022; T1007132021:61 BUD: 01/09/2022; T1009142021:95 BUD: 03/13/2022
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
- 21 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-0165-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.