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.
Reported: April 26, 2023 Initiated: April 6, 2023 #D-0537-2023
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.
Details
- Recalling Firm
- Pharma Nobis LLC
- Units Affected
- 69,615 bottles
- Distribution
- Nationwide in the USA
- Location
- Texarkana, TX
Frequently Asked Questions
What product 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.. Recalled by Pharma Nobis LLC. Units affected: 69,615 bottles.
Why was this product recalled? ▼
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 26, 2023. Severity: Moderate. Recall number: D-0537-2023.
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