FX.co ★ Brassica Pharma Recalls Eye Ointment Products For Sterility Concern

Based in Maharashtra, India, Brassica Pharma Pvt. Ltd. has issued a recall for its Eye Ointment products across various brands, as per the U.S Food and Drug Administration (FDA)'s announcement. The products, which have been sold through popular outlets such as Walmart and CVS, are being recalled due to concerns about sterility assurance at the manufacturing facility, as discovered during an FDA inspection.

The recalled Eye Ointment products include Equate Lubricant Eye Ointment (UPC code 681131395298), Equate Stye Lubricant Eye Ointment (UPC code 681131395304), CVS Health Lubricant Eye Ointment (UPC code 050428634141) and Lubricant PM Ointment (UPC code 371406124356). These products were packaged in 3.5-gram tubes and have expiration dates ranging from February 2024 to September 2025. The products were distributed nationwide to wholesalers, retailers, and through the product distributor, including Walmart, CVS, and AACE Pharmaceuticals Inc.

Eye drugs can pose an increased risk to consumers' health due to the fact that when applied, they bypass several of the body's natural protective mechanisms. The impacted products are intended to be sterile, meaning that using the recalled products could potentially lead to eye infections or related harm.

As of February 16, Brassica Pharma Pvt. Ltd. have not reported any adverse events related to the affected products.

The FDA has strongly encouraged distributors and retailers to halt distribution of the products, and has advised consumers to stop using them and return the products to their point of purchase.

In similar news, last month, Warren, New Jersey-based Haleon recalled eight lots of Robitussin-branded Honey CF Max Day Adult and Honey CF Max Nighttime Adult due to concerns of microbial contamination. Additionally, Windstone Medical Packaging, operating under the name Aligned Medical Solutions, has recalled Nurse Assist Sterile Saline in various convenience kits because the required sterility assurance level of 10-6 could not be confirmed.

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