Drug product
Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
D-0415-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 9 vials and b) 78 vials, c) 210 vials
- Official record key
drug-enforcement:D-0415-2017
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: 07222016@15 b) Known lot code: 04122016@17, 05182016@16, 09082016@28 c) Known lot code: 04072016@13, 05192016@22, 06132016@36, 08032016@35.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility