D-116-2013 Class II Terminated
FDA drug recall D-116-2013 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: 20 vials.
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
- 20 vials
Product Description
Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide
Code Information
All lot codes