Drug product
Puralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular Lubricant, Net Wt. 1 g (NDC 0574-4025-11) and Net Wt. 3.5 g (1/8 oz.) (NDC 0574-4025-35), Manufactured for Perrigo, Minneapolis, MN 55427
D-0358-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 195,864 unts
- Official record key
drug-enforcement:D-0358-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: RJH, Exp 10/19; SCC, Exp 3/21; SGA, Exp 7/21; SGH, Exp 7/21; SHH, Exp 8/21; SLL, Exp 12/21; TAC, Exp 1/22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility