woman dropping eye ointment
(Photo : Vecteezy/ Stefan Amer)

In a precautionary measure, Brassica Pharma has initiated a voluntary recall of four eye ointment products following an inspection by the Food and Drug Administration (FDA) that revealed a lack of sterility assurance at the facility. 

The recall, issued on Feb. 14, pertains to products with expiration dates ranging from February 2024 to September 2025.  

The affected products include Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, and AACE Pharmaceuticals' Lubricant PM Ointment.

According to the FDA, these ointments are commonly used for various eye conditions, and the lack of sterility assurance poses a potential risk of eye infections or other related harm to consumers.

"For those patients who use these products, there is a potential risk of eye infections or related harm.These products are intended to be sterile," said the risk statement accompanying the recall notice. "Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body's natural defenses."

Despite the recall, Brassica Pharma has not received any reports of adverse events related to the use of these eye ointments as of Feb. 16, according to the FDA.

The impacted products were distributed nationwide to wholesalers, retailers, and via product distributors such as Walmart, CVS, and AACE Pharmaceuticals. 

Brassica Pharma is actively notifying its distributors and retailers about the recall, urging them to cease distribution of the affected products.

Consumers who have purchased any of the recalled eye ointments are advised to discontinue use immediately and may return the products to the place of purchase for a refund. 

Both CVS and Walmart have confirmed the removal of these products from their shelves, offering full refunds to customers.

This recall comes in the wake of increased scrutiny by the FDA on eye products. The FDA has been actively monitoring manufacturing facilities and product quality to ensure consumer safety.

Consumers with questions regarding the recall can contact Brassica Pharma directly at +1 833-225-9564 or via email at info@brassicapharma.com. 

Additionally, any adverse reactions or quality problems experienced with the use of these products can be reported to the FDA's MedWatch Adverse Event Reporting program online or by contacting the FDA directly.

This voluntary recall is being conducted with the knowledge and cooperation of the U.S. FDA, highlighting the ongoing efforts to maintain the safety and integrity of pharmaceutical products in the market.