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Multiple Ophthalmic Products by Altaire Pharmaceuticals, Inc. Recall – Potential For Nonsterility

On July 3, 2019, Altaire Pharmaceuticals, Inc. voluntarily recalled various over-the-counter (OTC) eye drops and ointments sold exclusively at Walgreens. Altaire issued the retail level recall over quality concerns at their manufacturing facility. Administration of nonsterile ophthalmic medications can result in serious and potentially life-threatening infections. On July 10, 2019, Altaire Pharmaceuticals, Inc. also voluntarily recalled various OTC eye drops, gels, and ointments sold exclusively at CVS for the same concerns. Altaire has not received any reports of adverse events, and no products have failed sterility tests to date.

The recall affects 6 lots sold at Walgreens and 184 lots sold at CVS. The recall is only for the specific lots listed that are still within expiry. The detailed list of lot number, expiration, and manufacturer ship dates can be found in the links below.

The eye drops and ointments sold at Walgreens are manufactured for, shipped to, and sold exclusively by Walgreens. The eye drops, gels, and ointments sold at CVS are manufactured for, shipped to, and sold exclusively by CVS. Altaire notified both Walgreens and CVS of the recall, and gave specific directions on returning the affected products.

Walgreens and CVS pharmacies should cease distribution of the impacted lots and return the products to Altaire according to their specified instructions. Patients should stop taking their medication immediately, and report any adverse events to their health care providers. Patients with questions or concerns about this recall can contact Altaire Pharmaceuticals Inc., at 800-258-2471, or by email at otcdruggist@aol.com. Any adverse events may be reported to FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/safety/medwatch/.