Drug product
Trimix Injectable 30 mg/2 mg/20 mcg, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
D-0413-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 56 vials and b) 48 vials
- Official record key
drug-enforcement:D-0413-2017
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:05182016@17, 07222016@16, 08182016@27 b) Known lot code:03312016@7, 05192016@23, 08032016@34.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility