Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, CVS Product # 999532, UPC 0 50428 36475 8.

Recall Number: D-0537-2023

Firm: Pharma Nobis LLC

Classification: Class II

Status: Ongoing

Report Date: 20230426

Initiation Date: 20230406

Termination Date:

CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.

Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, CVS Product # 999532, UPC 0 50428 36475 8.