Drug product
MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
D-0368-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 633 vials
- Official record key
drug-enforcement:D-0368-2017
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: 04222016@4, 05112016@24, 05162016@14, 06082016@8, 06222016@42, 07272016@8
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility