Drug product
Titan Up (INOS/CHOL/LEU/CAR/CHRO/LID) Injectable 25 mg/25 mg/1.5 mg/25 mg/0.025 mg/10 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
D-0405-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 433 vials
- Official record key
drug-enforcement:D-0405-2017
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03252016@4, 04012016@9, 04042016@9, 04132016@14, 05062016@3, 06022016@7, 06152016@22, 06292016@25, 07282016@12.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility