Pharmaceutical distributor AvKARE released an urgent voluntary drug recall notice on its website that BRS Analytical Service, LLC is initiating a voluntary recall to the consumer level for several ophthalmic products.
According to the notice, the recall has been initiated due to manufacturing cGMP deviations identified during an audit by the US Food and Drug Administration (FDA). The announcement noted that “Health Hazard to the user is unknown, 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."
The below marketed products are subject to the recall:
- 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
According to the notice, the recall is being carried out with the knowledge of the FDA, and further use of this product should immediately cease.
These items were first shipped May 26, 2023, until April 21, 2025
For more details about the products being recalled, read the full notice here: https://www.avkare.com/recall The FDA has also published the number of cases in the recall here: https://www.accessdata.fda.gov/scripts/ires/?Event=96741