D-1160-2023 Class II Ongoing
FDA drug recall D-1160-2023 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: 282,564 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 27, 2023
- Initiation Date
- Sep 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 282,564 units
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.
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: 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;
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1160-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026