Drug product
Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20
D-0474-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 195,864 units
- Official record key
drug-enforcement:D-0474-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: RKM 11/19 SGA 7/20 SIF 9/20 SKE 11/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility