TRIPTROPIN PLUS INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Recall Number: D-1008-2013
Firm: Beacon Hill Medical Pharmacy, P.C.
Classification: Class II
Status: Terminated
Report Date: 20130918
Initiation Date: 20130726
Termination Date: 20140718
Reason for Recall
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Product Description
TRIPTROPIN PLUS INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI