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FDAFDA · Food and drugs·Recall number D-0537-2023

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.

Published April 26, 2023 · Recall initiated: April 6, 2023

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Pharma Nobis LLC
Distributor
Nationwide in the USA
Lot
Lots: A70293, A70294, A70295, Exp. 12/2023; A70746, A70747, A70748, A70749, Exp. 01/2024; A73051, A73052, Exp. 05/2024
Risk classification
Class II
Area (FDA)
drug
Country
United States

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