Why it was recalled
Lack of Assurance of Sterility
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.
Lot numbers, UPCs & expiration codes
Lot: YM308 EXP:10/24;
Where it was sold
Product was distributed to two (2) direct accounts in RI and CO.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1167-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 1, 2023
- FDA report date
- Sep 27, 2023
- Quantity
- 30,490 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AMMAN PHARMACEUTICAL INDUSTRIES
Original FDA data
Every field from FDA enforcement report D-1167-2023, exactly as published.
Show all FDA fields
- City
- Amman
- Status
- Ongoing
- Country
- Jordan
- Event ID
- 92974
- Address
- Building 108
- Address (line 2)
- Street A3, King Abdullah Ii Industrial City
- Code information
- Lot: YM308 EXP:10/24;
- Report date
- Sep 27, 2023
- Product type
- Drugs
- Recall number
- D-1167-2023
- Classification
- Class II
- Recalling firm
- AMMAN PHARMACEUTICAL INDUSTRIES
- Product quantity
- 30,490 units
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Product was distributed to two (2) direct accounts in RI and CO.
- Recall initiation date
- Sep 1, 2023
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2023