Drug product
MIC/B-COMPLEX 15 mg/50 mg/100 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
D-0374-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 984 vials
- Official record key
drug-enforcement:D-0374-2017
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. Known lot code: 04052016@5, 04082016@3, 04182016@37, 05032016@2, 05182016@3, 05232016@22, 06072016@18, 06282016@45, 07252016@52, 08262016@8.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility