FDAOctober 31, 2023drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

harvard drug group llc dba major pharmaceuticals and rugby laboratoriesharvardharvard drug

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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