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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livoni

Recalled November 29, 2023 · FDA recall D-0107-2024 · 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
1,271,810 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
Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.
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

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livoni | RecallWatchUSA