Status
Ongoing
Drug Enforcement D-1167-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
September 27, 2023
Termination Date
—
Product Information
- Product description
- 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.
- Product quantity
- 30,490 units
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to two (2) direct accounts in RI and CO.
Location & Firm
- Recalling firm
- AMMAN PHARMACEUTICAL INDUSTRIES
- Address
-
Building 108, Street A3, King Abdullah Ii Industrial City
Jordan - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1167-2023
- Event ID
- 92974
- Recall initiation date
- September 1, 2023
- Center classification date
- September 15, 2023
- Code info
- Lot: YM308 EXP:10/24;
- More code info
- —