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Eye Ointments Recalled Over Sterility Concerns

Eye Ointments affected by recall
Eye Ointments affected by recall | Image by FDA

Multiple eye ointments have been recalled due to unsanitary conditions at a manufacturing plant.

The Food and Drug Administration published on February 26 that Brassica Pharma Pvt. Ltd. announced a voluntary recall of multiple eye ointment medications. The company enacted this recall due to a “Potential Lack of Sterility Assurance” on February 22.

These products, therefore, bear a risk of causing eye infections.

“Ophthalmic drug products pose a potentially heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” read the company’s announcement, per the FDA. “To date, Brassica Pharma Pvt. Ltd. has not received any reports of adverse events up to 16th February 2024 related to this recall.”

Products affected by this recall proceed as follows:

  • Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%, Lanolin Alcohols)
  • Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid, Wheat Germ Oil)
  • CVS Health Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid Wheat Germ Oil
  • Lubricant PM Ointment

These products were sold in retail locations such as Walmart, CVS, and AACE Pharmaceuticals Inc., with expiration dates ranging from February 2024 through September 2025. Brassica Pharma Pvt. Ltd. has already begun notifying distributors of the recall, asking them to stop selling the products.

Those in possession of these products are advised to stop using them and return them to wherever they were purchased. Those who believe they are experiencing adverse health effects after using these products are advised to contact the FDA’s MedWatch Adverse Event Reporting program.

This recall is the most recent for potentially unsterile eye products. Pharmedica and Apotex announced recalls last year due to potential contamination risks in several of their eye drop products, as previously reported by The Dallas Express.

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