(NewsNation) — More than 75,000 cases of eye drops have been recalled in the United States, according to a new report.
Medical manufacturer AvKARE said the recalls occurred after the Food and Drug Administration found cases of artificial tears with several cGMP deviations, departing from the standard manufacturing process during pharmaceutical production. The eye drops — used to relieve itchy and dry eyes — were also recalled due to a lack of assurance of safety.
The recalled products include:
- NDC# 50268-043-15 Artificial Tears Ophthalmic Solution
- NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%
- NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution
- NDC# 50268-126-15 Lubricant Eye Drops Solution
- NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution
“This recall has been initiated due to manufacturing cGMP deviations identified during an audit by FDA,” AvKare said in a statement. “cGMP deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products.”
AvKARE said the recalled items were distributed and shipped between May 2023 and April 2025.