Safety risks related to more than 70,000 eye care products has prompted a voluntary recall by BRS Analytical Service, LLC, which is an independent contract testing laboratory. The products were distributed by AvKare.
The laboratory initiated the recall because of potential concerns regarding the quality and safety linked to the manufacturing process of the products involved in the recall. Serious manufacturing violations of Current Good Manufacturing Practice were noted in a recent FDA audit of the laboratory.
A Class II risk, which is the second-highest warning rating, was issued by the FDA for five ophthalmic solutions due to violations of current manufacturing practices. The five solutions involved are:
- Polyvinyl Alcohol Ophthalmic Solution (NDC#50268-678-15)
- Artificial Tears Ophthalmic Solution (NDC# 50268-043-15)
- Lubricant Eye Drops Solution (NDC# 50268-126-15)
- Carboxymethylcellulose Sodium Ophthalmic Solution (NDC# 50268-068-15)
- Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC# 50268-066-15)
While no specific hazards were listed, the digression from the Current Good Manufacturing Practice may cause the products to be of unacceptable quality. Customers are being told to discontinue use of the products and to return them.
For more information regarding the recall and how to return the item, please visit this link: https://www.avkare.com/recall
