Drug product
MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx
D-0063-2022
Product summary
- Event
- Event 88693
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0063-2022
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Code information: all lots within expiry
Distribution pattern: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility