NEW YORK—This week, the FDA posted a voluntary recall from Thane, Maharashtra, India, Brassica Pharma Pvt. Ltd. of several of its Eye Ointment products with expiration dates ranging from February 2024 to September 2025. The FDA explained on its website, “The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food and Drug Administration (FDA).” These eye ointment products are intended to be sterile. Brassica Pharma Pvt. Ltd. has not received any reports of adverse events up to Feb. 16, 2024 related to this recall.

As reported by WebMD, the recall applies to:

● 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.

These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Walmart, CVS and AACE Pharmaceuticals Inc. Brassica Pharma Pvt. Ltd. is notifying its distributors AACE Pharmaceuticals Inc and its retailers Walmart and CVS, and those distributors will further notify wholesalers and retailers via mail and arrange for return of all impacted products. Consumers who have the recalled products should stop use and return the products to the place of purchase. Consumers should also contact their health care provider if they have experienced any problems that may be related to using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is the latest of several warnings and recalls regarding eye drops, as reported by VMAIL.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.