Fast Acting Earwax Removal System recalled over manufacturing violations
- Recall date
- April 6, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Pharma Nobis LLC recalls Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by:…
- Recall number
- D-0537-2023
- FDA classification
- Class II
- Brand / firm
- Pharma Nobis LLC
- Sold / distributed
- Nationwide in the USA
Why it was recalled
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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.
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