MAJOR LubriFresh P — Class II drug recall D-1160-2023
Ongoing recall by AMMAN PHARMACEUTICAL INDUSTRIES, reported 2023-09-27, distributed in CO, RI. Lack of Assurance of Sterility
| Recall number | D-1160-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AMMAN PHARMACEUTICAL INDUSTRIES, Amman, Jordan |
| Recall initiated | 2023-09-01 |
| Classified | 2023-09-15 |
| Reported by FDA | 2023-09-27 |
| Distributed | CO, RI |
| Quantity | 282,564 units |
| Reason classes | sterility |
| NDC | 00904-6488-38 |
| Lot numbers | 11/24, 12/24, 184001, 184002, 184003, 184004, 184005, 184006 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1160-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.