FDA Drug recall D-0537-2023
Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc.,…
- FDA Drug
- Class II
- ongoing
- Published 2023-04-26
On 2023-04-26 the FDA classified a Class II recall of Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc.,… by Pharma Nobis, citing CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0537-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-06 |
| Published | 2023-04-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pharma Nobis |
| Distribution | US |
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.
Reason
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Identifiers
| upc | 050428364758 |
|---|---|
| code_info | Lots: A70293, A70294, A70295, Exp. 12/2023; A70746, A70747, A70748, A70749, Exp. 01/2024; A73051, A73052, Exp. 05/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0537-2023%22
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