The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2023-11-29 Health critical FDA
Health · FDA · Recall #FDA-D-0107-2024
Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist.… Recall
Issued November 29, 2023 · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
In November 2023, The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled the Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist.…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
What you should do
- 1 Stop using Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist.… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Category
- Health
- Recall date
- November 29, 2023
- Units affected
- Not reported
- Sold at
- Nationwide within the United States
- Recall number
- FDA-D-0107-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 12 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.