Status
Ongoing
Drug Enforcement D-1160-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
September 27, 2023
Termination Date
—
Product Information
- 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.
- Product quantity
- 282,564 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-1160-2023
- Event ID
- 92974
- Recall initiation date
- September 1, 2023
- Center classification date
- September 15, 2023
- Code info
- 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;
- More code info
- —