Drug product
MIC/B-COMP+CARN+LIDO, 15 mg/30 mg/30 mg/85 mg/20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
D-0372-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1716 vials
- Official record key
drug-enforcement:D-0372-2017
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: 03302016@9, 04072016@15, 05022016@14, 05052016@5, 05162016@16, 06012016@11, 06092016@30, 06152016@15, 06212016@2, 07152016@8, 08042016@21.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility