# FDA recall D-0108-2024

> **The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories** · Class I · drug recall initiated 2023-10-31.

## Product

Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94

## Reason for recall

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling  at the manufacturing facility.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0108-2024
- **Recalling firm:** The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-10-31
- **Report date:** 2023-11-29
- **Termination date:** 2025-04-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** La Vergne, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0108-2024

## Citation

> AI Analytics. FDA recall D-0108-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0108-2024. Source: US FDA. Licensed CC0.

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