# FDA recall D-0664-2024

> **AbbVie Inc.** · Class II · drug recall initiated 2024-09-16.

## Product

Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940,  UPC code: 300230667043,

## Reason for recall

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

## Distribution

Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)

## Key facts

- **Recall number:** D-0664-2024
- **Recalling firm:** AbbVie Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-09-16
- **Report date:** 2024-10-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Chicago, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0664-2024

## Citation

> AI Analytics. FDA recall D-0664-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0664-2024. Source: US FDA. Licensed CC0.

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