February 27, 2024 – Four eye lubricants, including some sold at Walmart and CVS, have been added to the growing list of probably contaminated over-the-counter eye products from India.
The FDA posted the recall notice on its website Monday. The recalled products are tubes of eye ointment. The recall particularly affects:
- 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 date of the affected tubes is between March 2024 and September 2025. The products were recalled following an inspection by U.S. regulators that found sterility issues within the manufacturing of the attention ointments.
India-based Brassica Pharma Pvt. Ltd. reported that as of February 16, it had not received any reports of adversarial events related to the ointments.
“Patients using these products are at potential risk of eye infections or related harm. … Ophthalmic medicines pose a possible increased risk to users because medications applied to the eyes bypass a few of the body's natural defenses,” said the corporate's recall notice, posted on the FDA recall website specified.
This is the most recent in a single Series of callbacks Due to the risk of infection, more than two dozen eye products are affected. Last year, officials strongly warned against using EzriCare's artificial tears, Delsam Pharma's artificial tears and Delsam Pharma's artificial ointment, all made by the same manufacturer. The products have been linked to bacterial infections affecting 81 people in 18 states. Many of those affected lived in long-term care facilities. The infections were associated with vision loss in 14 people and the need for surgical removal of the eyeball in four people.
For this latest recall, consumers in possession of the product may return the product to where they purchased it and contact Brassica Pharma Pvt. turn around. Ltd. For questions call 833-225-9564 or [email protected].
People who have had problems that may be related to the use of the eye ointments should contact their doctor and adverse reactions should be reported to the FDA MedWatch Adverse Event Reporting Program.