Drug product
MIC-CARN MAX 15/100/50/1 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
D-981-2013
Product summary
- Event
- Event 65876
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-981-2013
Official wording
Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Code information: 03192013@29, 01242013@28, 05212013@23, 06252013@1 and 07022013@27
Distribution pattern: USA nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility