Recalls / Class II
Class IID-0537-2023
Product
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.
- Affected lot / code info
- Lots: A70293, A70294, A70295, Exp. 12/2023; A70746, A70747, A70748, A70749, Exp. 01/2024; A73051, A73052, Exp. 05/2024
Why it was recalled
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Recalling firm
- Firm
- Pharma Nobis LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7400 Alumax Rd, N/A, Texarkana, Texas 75501-0282
Distribution
- Quantity
- 69,615 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-04-06
- FDA classified
- 2023-04-14
- Posted by FDA
- 2023-04-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0537-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.