D-0537-2023 Class II Ongoing
FDA drug recall D-0537-2023 was initiated by Pharma Nobis LLC on Apr 6, 2023 and is designated Class II. Reason for recall: CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation. The recall status is ongoing. Affected quantity: 69,615 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 26, 2023
- Initiation Date
- Apr 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69,615 bottles
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lots: A70293, A70294, A70295, Exp. 12/2023; A70746, A70747, A70748, A70749, Exp. 01/2024; A73051, A73052, Exp. 05/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0537-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026