Drug product
Puralube Petrolatum Ophthalmic Ointment, Net Wt 3.5 gram (1/8 oz), Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-35
D-0473-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 273,100 units
- Official record key
drug-enforcement:D-0473-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: RJH 10/19 SCC 3/21 SGA 7/21 SGH 7/21 SHH 8/21 SLL 12/21 TAC 1/22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility