26 February 2024
TOPEKA (KSNT) – The Food and Drug Administration (FDA) says multiple eye ointment products are being recalled due to a lack of sterilization.
The FDA said Brassica Pharma Pvt. Ltd. based out of India is voluntarily recalling several of its eye ointments as a recent inspection found the products lacked sterility. This poses a health risk to those using the eye ointment products in the form of eye infections. Products applied directly to the eyes can bypass a person’s natural defenses, leading to a greater risk of infection.
No reports of illness have been received to date by the FDA in connection to the recalled eye ointments. All of the recalled products have expiration dates ranging from February 2024 to September 2025. Each product was sold in a cardboard box in a size 3.5 gram tube.
The recalled products were sold nationwide to retailers like Walmart, CVS and AACE Pharmaceuticals Inc. More information on the recalled eye ointments can be found below:
Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%, Lanolin Alcohols)
UPC: 681131395298
NDC: 79903-026-35
Lot # Expiration Date: A2E01 in April 2024, A2L05 in Nov. 2024, A3B01 in Jan. 2025, A3C01 in Feb. 2025 and A3H05 in July 2025.
Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid, Wheat Germ Oil)
UPC: 681131395304
NDC: 79903-028-35
Lot # Expiration Date: A2D08 in March 2024, A2F02 in May 2024, A2I03 in Aug. 2024, A2L03 in Nov. 2024, A3C03 in Feb. 2025, A3C05 in Feb. 2025, A3H01 in July 2025 and A3H03 in July 2025.
CVS Health Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid Wheat Germ Oil
UPC: 050428634141
NDC: 76168-707-35
Lot # Expiration Date: A2F03 in May 2024, A2I02 in Aug. 2024, A2L02 in Nov. 2024, A3C04 in Feb. 2025 and A3H04 in July 2025.
Lubricant PM Ointment – AACE Pharmaceuticals
UPC: 371406124356
NDC: 71406-124-35
Lot #Expiration Date: A2G01 in June 2024, A2G02 in June 2024, A3F08 in May 2025, A3F09 in May 2025, A3J17 in Sept. 2025 and A3J18 in Sept. 2025.
If you purchased any of the above products, the FDA encourages you to stop using them and return them to the place of purchase. If you have any health concerns, you are encouraged to contact your healthcare provider.
If you have questions for Brassica Pharma Pvt. Ltd., you can contact the company at 1-833-225-9564 or send an email to [email protected]. If you have experienced illness in connection to the recalled eye ointment products, you can make a report to the FDA’s MedWatch Adverse Event Reporting program online, by mail or fax. To report by mail or fax, click here to download a form or call 1-800-332-1088. You can submit forms by fax through 1-800-FDA-0178.
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