Major Pharmaceuticals recalls Polyvinyl Alcohol 1.4% lubricating eye drops due to non-sterility risks from manufacturing facility contamination. All bottles are affected.
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Major Pharmaceuticals is recalling all Polyvinyl Alcohol 1.4% lubricating eye drops bottles because the manufacturing facility had unsanitary conditions and bacterial contamination. This could lead to eye infections if used.
The manufacturing facility had unsanitary conditions and positive bacterial tests, meaning the eye drops could contain harmful bacteria. Using contaminated eye drops might cause eye infections, especially for people with weakened immune systems.
People who own or use these eye drops are affected. Those with compromised immune systems may be at higher risk due to potential bacterial contamination.
Check for Polyvinyl Alcohol 1.4% lubricating eye drops in 0.5 fl oz (15mL) bottles. The product is distributed by Rugby Laboratories in Livonia, MI. All lots are affected.
Look for the product name and packaging details to confirm if it matches the recalled items.
The FDA found bacterial contamination in the manufacturing facility, so the product is not safe to use. It could cause eye infections.
Check for Polyvin:yl Alcohol 1.4% lubricating eye drops in 0.5 fl oz (15mL) bottles distributed by Rugby Laboratories in Livonia, MI. All lots are affected.
The recall covers all lots, so you should stop using the product and contact the manufacturer for further instructions.
We’ve drafted a message you can send Major Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0107-2024 — Major Pharmaceuticals Major Pharmaceuticals Hello, I own a Major Pharmaceuticals that is covered by recall D-0107-2024 from Major Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
