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Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle,...

FDA Recall #D-0537-2023 — Class II — April 6, 2023

Recall #D-0537-2023 Date: April 6, 2023 Classification: Class II Status: Ongoing

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.

Recalling Firm

Pharma Nobis LLC — Texarkana, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

69,615 bottles

Distribution

Nationwide in the USA

Code Information

Lots: A70293, A70294, A70295, Exp. 12/2023; A70746, A70747, A70748, A70749, Exp. 01/2024; A73051, A73052, Exp. 05/2024

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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