---
title: "MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.... — FDA record D-1160-2023 | Is It on Recall"
description: "Lack of Assurance of Sterility"
url: https://isitonrecall.com/recall/fda-drug-d-1160-2023-major-lubrifresh-p-m-nighttime-ointment-lubricant-eye-ointment-sterile-0-125-oz-3-5g-distributed-by/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHA... — FDA record D-1160-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Lack of Assurance of Sterility
- **Classification**: Class II
- **Recalling firm**: AMMAN PHARMACEUTICAL INDUSTRIES
- **Quantity**: 282,564 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: D-1160-2023

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1160-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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; |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Product was distributed to two (2) direct accounts in RI and CO.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Colorado](https://isitonrecall.com/state/colorado/)
- [Rhode Island](https://isitonrecall.com/state/rhode-island/)

## Dates in the source

- **Report date**: Sep 27, 2023
- **Recall initiation date**: Sep 1, 2023
- **Center classification date**: Sep 15, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1160-2023%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [AMMAN PHARMACEUTICAL INDUSTRIES records](https://isitonrecall.com/brand/amman-pharmaceutical-industries/)