Recalls / Class II
Class IID-1167-2023
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.
- Affected lot / code info
- Lot: YM308 EXP:10/24;
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- AMMAN PHARMACEUTICAL INDUSTRIES
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Building 108, Street A3, King Abdullah Ii Industrial City, Amman, N/A, Jordan
Distribution
- Quantity
- 30,490 units
- Distribution pattern
- Product was distributed to two (2) direct accounts in RI and CO.
Timeline
- Recall initiated
- 2023-09-01
- FDA classified
- 2023-09-15
- Posted by FDA
- 2023-09-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1167-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.