D-1066-2014 Class II Terminated
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