Drug product
Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
D-119-2013
Product summary
- Event
- Event 63305
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7055 vials
- Official record key
drug-enforcement:D-119-2013
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