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OTC Eye Ointments Recalled for Sterility Concerns
Over-the-counter eye ointments distributed by Walmart, CVS Pharmacy, and AACE Pharmaceuticals Inc. are being voluntarily recalled by Brassica Pharma Pvt. Ltd. due to a lack of sterility assurance. The company initiated the recall after a US Food and Drug Administration (FDA) inspection of the manufacturing facility in Thane, Maharashtra, India.
According to a February 22, 2024, statement from Brassica Pharma and the March 6, 2024, FDA Enforcement Report, the recall affects the following eye ointment products, which were distributed throughout the United States:
- Equate Lubricant Eye Ointment (mineral oil 42.5%, white petrolatum 57.3%, lanolin alcohols), packaged in 3.5 g tubes (NDC 79903-026-35, UPC 681131395298), distributed by Walmart Inc., Bentonville, Arkansas, from lots A2E01 (Exp. 4/24), A2L05 (Exp. 11/24), A3B01 (Exp. 1/25), A3C01 (Exp. 2/25), and A3H05 (Exp. 7/25);
- Equate Stye Lubricant Eye Ointment (mineral oil 31.9%, white petrolatum 57.7%, microcrystalline wax, stearic acid, wheat germ oil), packaged in 3.5 g tubes (NDC 79903-028-35, UPC 681131395304), distributed by Walmart Inc., from lots A2D08 (Exp. 3/24), A2F02 (Exp. 5/24), A2I03 (Exp. 8/24), A2L03 (Exp. 11/24), A2L04 (Exp. 11/24), A3C03 (Exp. 2/25), A3C05 (Exp. 2/25), A3H01 (Exp. 7/25), and A3H03 (Exp. 7/25);
- CVS Health Lubricant Eye Ointment (mineral oil 31.9%, white petrolatum 57.7%, microcrystalline wax, stearic acid, wheat germ oil), packaged in 3.5 g tubes (NDC 76168-707-35, UPC 050428634141), distributed by CVS Pharmacy Inc., Woonsocket, Rhode Island, from lots A2F03 (Exp. 5/24), A2I02 (Exp. 8/24), A2L02 (Exp. 11/24), A3C04 (Exp. 2/25), and A3H04 (Exp. 7/25); and
- Lubricant PM Ointment (mineral oil 42.5% and white petrolatum 57.3%), packaged in 3.5 g tubes (NDC 71406-124-35, UPC 371406124356), distributed by AACE Pharmaceuticals Inc., Fairfield, New Jersey, from lots A2G01 (Exp. 6/24), A2G02 (Exp. 6/24), A3F08 (Exp. 5/25), A3F09 (Exp. 5/25), A3J17 (Exp. 9/25), and A3J18 (Exp. 9/25).
Brassica Pharma initiated the recall on January 30, 2024. On February 28, 2024, the FDA designated the recall Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Brassica Pharma said as of mid-February it had not received any reports of adverse events related to the recalled products.
