Drug product
Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1(877) BELLA.
D-1156-2017
Product summary
- Event
- Event 77959
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 bottles
- Official record key
drug-enforcement:D-1156-2017
Official wording
Reason: Lack of Assurance of Sterility.
Code information: Lot #: BPLG3508717, Exp. 11/7/17
Distribution pattern: Nationwide within USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility