Drug product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 2.5 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
D-0205-2022
Product summary
- Event
- Event 88862
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 vials
- Official record key
drug-enforcement:D-0205-2022
Official wording
Reason: Lack of assurance of sterility
Code information: Lot: 07222021:11 BUD: 11/30/2021; 08172021:72 BUD: 02/08/2022; 06282021:84 BUD: 10/23/2021; 07132021:93 BUD: 10/23/2021; 09102021:43 BUD: 02/08/2022
Distribution pattern: United States including Washington, D.C. and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility