Drug product
Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
D-1160-2017
Product summary
- Event
- Event 77959
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,334 syringes
- Official record key
drug-enforcement:D-1160-2017
Official wording
Reason: Lack of Assurance of Sterility.
Code information: Lot #: 3141201, Exp. 9/13/17; 3146966, Exp . 9/20/17; 3160608, Exp. 10/5/17; 3146966, Exp. 11/1/17
Distribution pattern: Nationwide within USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility