Why it was recalled
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
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.
Lot numbers, UPCs & expiration codes
Lots: A70293, A70294, A70295, Exp. 12/2023; A70746, A70747, A70748, A70749, Exp. 01/2024; A73051, A73052, Exp. 05/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0537-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 6, 2023
- FDA report date
- Apr 26, 2023
- Quantity
- 69,615 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharma Nobis LLC
Original FDA data
Every field from FDA enforcement report D-0537-2023, exactly as published.
Show all FDA fields
- City
- Texarkana
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 92080
- Address
- 7400 Alumax Rd
- Code information
- Lots: A70293, A70294, A70295, Exp. 12/2023; A70746, A70747, A70748, A70749, Exp. 01/2024; A73051, A73052, Exp. 05/2024
- Postal code
- 75501-0282
- Report date
- Apr 26, 2023
- Product type
- Drugs
- Recall number
- D-0537-2023
- Classification
- Class II
- Recalling firm
- Pharma Nobis LLC
- Product quantity
- 69,615 bottles
- Reason for recall
- CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 6, 2023
- Initial firm notification
- Letter
- Center classification date
- Apr 14, 2023