D-1167-2023 Class II Ongoing
FDA drug recall D-1167-2023 was initiated by AMMAN PHARMACEUTICAL INDUSTRIES on Sep 1, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 30,490 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 27, 2023
- Initiation Date
- Sep 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,490 units
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.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Product was distributed to two (2) direct accounts in RI and CO.
Code Information
Lot: YM308 EXP:10/24;
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1167-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026