Drug product
Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20
D-0152-2020
Product summary
- Event
- Event 83833
- Status
- Terminated
- Classification
- Class II
- Quantity
- 808 droptainers
- Official record key
drug-enforcement:D-0152-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lot #: 138-20190205@3, Exp . Date 10/29/2019; 138-20190705@7, Exp. Date 11/3/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility