Drug product
Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA
D-122-2013
Product summary
- Event
- Event 63305
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8919 vials
- Official record key
drug-enforcement:D-122-2013
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