FDA-Drug2023-04-26Class II
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.
Pharma Nobis LLC
Hazard
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Sold states
Nationwide in the USA
Affected count
69,615 bottles
Manufactured in
7400 Alumax Rd, N/A, Texarkana, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0537-2023Don't want to check this manually?
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