# FDA recall D-0404-2025

> **BRS Analytical Services, LLC** · Class II · drug recall initiated 2025-04-23.

## Product

Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.

## Reason for recall

cGMP deviations and lack of assurance of sterility.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0404-2025
- **Recalling firm:** BRS Analytical Services, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-04-23
- **Report date:** 2025-05-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Louis, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0404-2025

## Citation

> AI Analytics. FDA recall D-0404-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0404-2025. Source: US FDA. Licensed CC0.

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