Drug product
Trimix Injectable 17.65 mg/0.59 mg/5.9 mcg/mL a) 2 mL, b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
D-0414-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 2 vials b) 3 vials and c) 7 vials
- Official record key
drug-enforcement:D-0414-2017
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. a) Known lot code: 07192016@25 b) Known lot code 06202016@157 c) Known lot code: 05042016@16.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility