D-054-2013 Class II Terminated
FDA drug recall D-054-2013 was initiated by Ameridose LLC on October 31, 2012 and is designated Class II. Reason for recall: Lack of assurance of sterility The recall status is terminated (terminated July 25, 2016).
Recall Details
- Product Type
- Drugs
- Report Date
- November 21, 2012
- Initiation Date
- October 31, 2012
- Termination Date
- July 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com
Reason for Recall
Lack of assurance of sterility
Distribution Pattern
Nationwide
Code Information
All lot codes within expiry