Drug product
Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
D-117-2013
Product summary
- Event
- Event 63305
- Status
- Terminated
- Classification
- Class II
- Quantity
- 165 vials
- Official record key
drug-enforcement:D-117-2013
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