(TNS) — Brassica Pharma Pvt. Ltd. has voluntarily recalled eye ointment products with an expiration date ranging from Feb. 2024 to Sept. 2025, due to a possible lack of sterility.
The problem was discovered during an inspection conducted by the Food and Drug Administration (FDA).
For those who have used Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment or Lubricant PM Ointment, there is a potential risk of eye infections because the products are supposed to be sterile.
Ophthalmic drug products pose a potentially heightened risk of harm to users because the drug applied to the eyes bypasses some of the body’s natural defenses, according to the FDA.
Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment and Lubricant PM Ointment were distributed nationwide to wholesalers, retailers, and via the product distributor, to Walmart, CVS and AACE Pharmaceuticals Inc., according to the FDA.
Brassica Pharma Pvt. Ltd. announced the recall on Feb. 22. To date, the company has not received any reports of adverse events up to Feb. 16 related to this recall.
Consumers, distributors and retailers who have any of the recalled products should cease distribution of the product. If you have any of these products, cease use and return it to where you bought it.
If you have questions regarding this recall, contact Brassica Pharma Pvt. Ltd. at 833-225-9564 or info@brassicapharma.com. Contact your physician or healthcare provider if you have experienced any problems that might be related to taking or using this product.
Adverse reactions or quality problems can be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. You can download the form, or call 800-332-1088 to request a reporting form, then complete and return it to the address listed, or submit it by fax to 800-FDA-0178.