Drug product
MAGNESIUM CHLORIDE HEXAHYDRATE 20% 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-976-2013
Product summary
- Event
- Event 65876
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-976-2013
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: 01212013@10, 03042013@26, 04032013@23, 04222013@26, 06052013@12, 06122013@27, 07032013@7, 07092013@21, 07152013@40, 07262013@21
Distribution pattern: USA nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility