Earwax Removal System Pulled for Subpotency

Pharma Nobis is recalling 69,615 bottles of an over-the-counter earwax removal product sold by CVS Pharmacy because its active ingredient may be subpotent before the expiration date. The recall was announced in the April 26, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 fluid ounce (15 mL) drops per bottle (CVS product 999532, UPC 0 50428 36475 8), from lots A70293, A70294, and A70295 (Exp 12/23); A70746, A70747, A70748, and A70749 (Exp 1/24); and A73051 and A73052 (Exp 5/24). The product was distributed by CVS Pharmacy Inc, Woonsocket, Rhode Island, throughout the United States. 

Pharma Nobis voluntarily initiated the recall April 6, 2023. The FDA designated the recall Class II on April 14, 2023. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.