D-1066-2014 Class II Terminated
FDA drug recall D-1066-2014 was initiated by Apothecure, Inc on April 15, 2013 and is designated Class II. 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. The recall status is terminated (terminated December 9, 2016).
Recall Details
- Product Type
- Drugs
- Report Date
- February 12, 2014
- Initiation Date
- April 15, 2013
- Termination Date
- December 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.
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.
Distribution Pattern
Nationwide
Code Information
All Lots