Drug product
MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
D-0399-2019
Product summary
- Event
- Event 81883
- Status
- Terminated
- Classification
- Class II
- Quantity
- 310 ml
- Official record key
drug-enforcement:D-0399-2019
Official wording
Reason: Lack of sterility assurance.
Code information: 1) 10192018@8 exp 2/28/19, MIC Ba w/ aminos 2) 10292018@15 exp 1/31/19, MIC B
Distribution pattern: Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Derived failure modes
-
Sterility assurance
Lack of sterility