Drug product
Bimix 30 mg/1 mg/mL Injectable, a) 5 mL and b) 10 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL
D-0343-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 80 vials, b) 23 vials
- Official record key
drug-enforcement:D-0343-2017
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: 04012016@7, 04252016@17, 05262016@13, 06142016@39, 08052016@13 b) Known lot code: 05242016@11, 09072016@18
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility