# FDA recall D-0293-2024

> **Kilitch Healthcare India Limited** · Class I · drug recall initiated 2023-11-13.

## Product

Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94

## Reason for recall

Non-Sterility

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0293-2024
- **Recalling firm:** Kilitch Healthcare India Limited
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-11-13
- **Report date:** 2024-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Navi Mumbai, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0293-2024

## Citation

> AI Analytics. FDA recall D-0293-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0293-2024. Source: US FDA. Licensed CC0.

---

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