Harvard Drug Group Recalls Eye Drops

The Harvard Drug Group (doing business as Major Pharmaceutical and Rugby Laboratories) has recalled all lots of polyvinyl alcohol, 1.4% lubricating eye drops and lubricating tears eye drops (dextran/hypromellose, 0.1%/0.3%). The products are supplied by Velocity Pharma and Harvard Drug Group received information from FDA about an investigator finding “insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility,” a recall notice says.

The notice says patients who use the products face a potential risk of eye infections that could result in partial vision loss or blindness. These products are intended to be sterile. Harvard Drug Group has received three adverse event reports related to the products including reports of vision blurriness, vision loss, and burning eyes, it adds.