The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUG

Recalled November 29, 2023 · FDA recall D-0108-2024 · The Harvard Drug Group LLC

Hazard

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

Units

65,880 bottles

Sold at

Nationwide within the United States

Description

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

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

Manufacturer(s)

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →