Drug product
octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15.
D-1167-2023
Product summary
- Event
- Event 92974
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 30,490 units
- Official record key
drug-enforcement:D-1167-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: YM308 EXP:10/24;
Distribution pattern: Product was distributed to two (2) direct accounts in RI and CO.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility