Four eye ointments are being voluntarily recalled after a Food and Drug Administration (FDA) inspection noted a “lack of sterility assurance” at the facility where the products were held.
The FDA on Monday published the Brassica Pharma Pvt. Ltd. company announcement from Feb. 12, which warned patients that “there is a potential risk of eye infections or related harm” if they use the products. The announcement instructed patients to stop using them.
The company said that as of Feb. 16, it had not received any reports of “adverse events” related to the recall. It invited consumers to return the products to specified locations or to the place of purchase.
The four ointments were all in packaged in cardboard boxes, in a 3.5-gram tube, and the expiration date ranged from February 2024 to September 2025.
Two ointments were manufactured under the brand, Equate. Another ointment was CVS Health, and another was AACE Pharmaceuticals.
All of the ointments recalled were distributed nationally to wholesalers, retailers, and via the product distributor, and the company is arranging for the return of any impacted products. The company is encouraging those with adverse reactions to notify the company.
The products include:
- Equate Lubricant Eye Ointment (Mineral Oil 42.5 percent, White Petrolatum 57.3 percent, Lanolin Alcohols), with UPC Code 681131395298 and NDC 79903-026-35.
- Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9 percent, White Petrolatum 57.7 percent, Microcrystalline Wax, Stearic Acid, Wheat Germ Oil), with UPC Code 681131395304 and NDC 79903-028-35.
- CVS Health Lubricant Eye Ointment (Mineral Oil 31.9 percent, White Petrolatum 57.7 percent, Microcrystalline Wax, Stearic Acid Wheat Germ Oil, with UPC Code 050428634141 and NDC 76168-707-35.
- Lubricant PM Ointment by AACE Pharmaceuticals, with UPC Code 371406124356, 71406-124-35.
Source: The Hill