Drug product
MIC+B12(M)+Carnitine 12.5 mg/50 mg/100 mg/1 mg/50 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
D-0376-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 159
- Official record key
drug-enforcement:D-0376-2017
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: 03252016@5, 04192016@8, 05242016@15, 06222016@28, 08102016@2.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility