Drug product
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
D-116-2013
Product summary
- Event
- Event 63305
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 vials
- Official record key
drug-enforcement:D-116-2013
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lot codes
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility