Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
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