Drug product
Trimix Injectable 30 mg/3 mg/100 mcg/mL, a) 5 mL and 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
D-0417-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 1 vial and b) 12 vials
- Official record key
drug-enforcement:D-0417-2017
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@7 b) Known lot code: 04122016@18.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility