The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.
Recall Number: D-1066-2014
Firm: Apothecure, Inc
Classification: Class II
Status: Terminated
Report Date: 20140212
Initiation Date: 20130415
Termination Date: 20161209
Reason for Recall
Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
Product Description
The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.