PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: April 26, 2023 Initiated: April 6, 2023 #D-0537-2023

Product Description

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.

Details

Recalling Firm
Pharma Nobis LLC
Units Affected
69,615 bottles
Distribution
Nationwide in the USA
Location
Texarkana, TX

Frequently Asked Questions

What product was recalled?
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.. Recalled by Pharma Nobis LLC. Units affected: 69,615 bottles.
Why was this product recalled?
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 26, 2023. Severity: Moderate. Recall number: D-0537-2023.