D-114-2013 Class II Terminated
FDA drug recall D-114-2013 was initiated by New England Compounding Center on September 26, 2012 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated October 7, 2016). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- January 9, 2013
- Initiation Date
- September 26, 2012
- Termination Date
- October 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide
Code Information
All lot codes