Brassica Pharma Recalls Eye Ointment Products For Sterility Concern

(RTTNews) - Maharashtra, India-based Brassica Pharma Pvt. Ltd. has recalled Eye Ointment products under multiple brands, according to the U.S Food and Drug Administration or FDA.

These products, sold through Walmart, CVS and others, are being called back due to lack of sterility assurance at the facility during an inspection conducted by the FDA.

The recalled ointments include Equate Lubricant Eye Ointment with UPC code 681131395298, Equate Stye Lubricant Eye Ointment with UPC code 681131395304, CVS Health Lubricant Eye Ointment with UPC code 050428634141 and Lubricant PM Ointment with UPC code 371406124356.

The impacted products were packed in 3.5-gram tubes with expiration dates ranging from February 2024 to September 2025. They were distributed nationwide to wholesalers, retailers, and through the product distributor, Walmart, CVS and AACE Pharmaceuticals Inc.

Ophthalmic drug products may pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body's natural defenses.

These products are intended to be sterile, and people who use the impacted products may get potential eye infections or related harm.

The company has not received any reports of adverse events up to February 16 related to the affected products.

The agency urged distributors and retailers to cease their distribution, and asked consumers to stop using the impacted products and return them to the place of purchase.

In similar recalls, Warren, New Jersey-based Haleon last month recalled eight lots of Robitussin branded Honey CF Max Day Adult and Honey CF Max Nighttime Adult citing microbial contamination.

Windstone Medical Packaging, doing business as Aligned Medical Solutions, recalled Nurse Assist Sterile Saline in various convenience kits because it cannot be verified as having the required sterility assurance level or SAL of 10-6.

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