Why it was recalled
Lack of Assurance of Sterility
Product description
MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38.
Lot numbers, UPCs & expiration codes
Lot: 184001 EXP: 11/24; 184002 EXP: 11/24; 184003 EXP: 11/24; Lot: 184004 EXP: 12/24; Lot: 184005 EXP: 12/24; Lot:184006 EXP:12/24;
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-1160-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 1, 2023
- FDA report date
- Sep 27, 2023
- Quantity
- 282,564 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AMMAN PHARMACEUTICAL INDUSTRIES
Original FDA data
Every field from FDA enforcement report D-1160-2023, 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: 184001 EXP: 11/24; 184002 EXP: 11/24; 184003 EXP: 11/24; Lot: 184004 EXP: 12/24; Lot: 184005 EXP: 12/24; Lot:184006 EXP:12/24;
- Report date
- Sep 27, 2023
- Product type
- Drugs
- Recall number
- D-1160-2023
- Classification
- Class II
- Recalling firm
- AMMAN PHARMACEUTICAL INDUSTRIES
- Product quantity
- 282,564 units
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38.
- 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