Feb. 27, 2024 – Four eye lubricant products, including some sold at Walmart and CVS, have been added to the growing list of potentially contaminated over-the-counter eye products made in India.
The FDA posted the recall notice on its website Monday. The recalled products are tubes of eye ointments, and the recall specifically 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
The expiration dates of affected tubes range from March 2024 to September 2025. The products were recalled after an inspection by U.S. regulators, which found sterility problems where the eye ointments are made.
India-based Brassica Pharma Pvt. Ltd. reported that it had not received any reports of adverse events related to the ointments as of Feb. 16.
“For those patients who use these products, there is a potential risk of eye infections or related harm. … Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” the company’s recall notice posted on the FDA’s recall webpage stated.
This is the latest in a string of recalls affecting more than two dozen eye products due to infection risks. Last year, officials urgently warned people to stop using EzriCare Artificial Tears, Delsam Pharma’s Artificial Tears, and Delsam Pharma’s Artificial Ointment, which all were made by the same manufacturer. The products were linked to bacterial infections affecting 81 people in 18 states. A number of affected people lived in long-term care facilities. The infections were linked to vision loss in 14 people and the need for surgical eyeball removal in four people.
For this latest recall, consumers who have the product can return the item where they bought it and may contact Brassica Pharma Pvt. Ltd. with any questions at 833-225-9564 or [email protected].
People who had any problems that may be related to using the eye ointments should contact their health care provider, and bad reactions should be reported to the FDA’s MedWatch Adverse Event Reporting program.