Drug product
MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38.
D-1160-2023
Product summary
- Event
- Event 92974
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 282,564 units
- Official record key
drug-enforcement:D-1160-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 184001 EXP: 11/24; 184002 EXP: 11/24; 184003 EXP: 11/24; Lot: 184004 EXP: 12/24; Lot: 184005 EXP: 12/24; Lot:184006 EXP:12/24;
Distribution pattern: Product was distributed to two (2) direct accounts in RI and CO.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility