Drug product
Perrigo Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile, Rx only, Net Wt 3.5 g, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4190-35
D-0357-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 41148 units
- Official record key
drug-enforcement:D-0357-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: RJD, Exp 10/19; SHG, Exp 8/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility