# FDA recall D-1160-2023

> **AMMAN PHARMACEUTICAL INDUSTRIES** · Class II · drug recall initiated 2023-09-01.

## 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

## Distribution

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

## Key facts

- **Recall number:** D-1160-2023
- **Recalling firm:** AMMAN PHARMACEUTICAL INDUSTRIES
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-09-01
- **Report date:** 2023-09-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Amman, Jordan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1160-2023

## Citation

> AI Analytics. FDA recall D-1160-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-1160-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*