Drug product
MIC/B12/CAR/CHR/LYS/DMG 25 mg/50 mg/50 mg/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL Injectable, 30 mL vial, Injectable, Compounded by Wells Pharmacy, Ocala, FL
D-0369-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 106 vials
- Official record key
drug-enforcement:D-0369-2017
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: 06292016@10, 08092016@19, 08232016@5.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility