FDA recall D-0537-2023

Product

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.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2023-04-06

Report date

2023-04-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Texarkana, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0537-2023