FDA Issues Voluntary Recall of Eye Ointments Available at CVS and Walmart Over Sterility Worries

FDA Product recall eyes

By Jackelyn Cornejo , Parent Herald Feb 28, 06:21 am

Undeniable eye ointment products, accessible at select Walmart and CVS stores, are being recalled due to considerations about the manufacturing facility's possible inadequacy of sanitation in India.

FDA Recalls Eye Ointments Over Sterility

Brassica Pharma Pvt. Ltd., a company based in Maharashtra, India, acknowledged the recall in response to an FDA inspection highlighting a "lack of sterility assurance at the facility."

The affected items include Equate brand Lubricant Eye Ointment and Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, and AACE Pharmaceuticals Lubricant PM Ointment. The recall notice emphasizes the risk of potential eye infections or harm, stating that these products are designed to be sterile, and ophthalmic drug products pose an elevated risk as they bypass natural defenses.

The announcement doesn't specify the types of infections or details about the manufacturing facility issues. Brassica Pharma, the manufacturer, did not provide further information or comments upon request.

As of February 16, Brassica Pharma reported no received complaints about infections or injuries related to the recalled ointments. However, the company recommended consumers to discontinue using the products, which have termination dates between February 2024 and September 2025.

Consumers can return the products to the stores of purchase. The 3.5-gram tubes are packaged in cardboard boxes. This recall follows an occurrence where deteriorated eyedrops caused major eye disease, leading to important health residue for users.

The FDA has been issuing recalls related to numerous eyedrop products, intensifying the concern of reporting any problems or adverse occurrences to healthcare providers and through the FDA's adverse occurrence reporting program.

List of Recalled Eye Ointments

The FDA released a recall notice on its website on Monday for certain tubes of eye ointments.

The recall is specific to the following products:

Equate Lubricant Eye Ointment with UPC number 681131395298 and lot numbers A2E0, A2L05, A3B01, A3C01, and A3H05.
Equate Stye Lubricant Eye Ointment with UPC number 681131395304 and lot numbers A2D08, A2F02, A2I03, A2L03, A2L04, A3C03, A3C05, A3H01, and A3H03.
CVS Health Lubricant Eye Ointment with UPC number 050428634141 and lot numbers A2F03, A2I02, A2L02, A3C04, and A3H04.
AACE Pharmaceuticals Lubricant PM Ointment with UPC number 371406124356 and lot numbers A2G01, A2G02, A3F08, A3F09, A3J17, and A3J18.

The affected tubes have expiration dates ranging from March 2024 to September 2025.

The recall follows a U.S. regulator's inspection that revealed sterility issues at the manufacturing site of these eye ointments, which are produced by India-based Brassica Pharma Pvt. Ltd. As of February 16, the company reported no adverse events related to the ointments.

The recall notice emphasizes a potential risk of eye infections or harm for users, particularly highlighting the elevated risk associated with ophthalmic drug products that bypass natural defenses.

This incident is part of a series of recalls involving over two dozen eye products due to infection risks. In a similar context, the recall advises consumers to return the product to the place of purchase and provides contact information for Brassica Pharma Pvt. Ltd. for inquiries.

Individuals experiencing problems possibly linked to the use of these eye ointments are encouraged to reach out to their healthcare provider, and any adverse reactions should be reported to the FDA's MedWatch Adverse Event Reporting program.