CLASS II ONGOING Drug recall · Reported 26 Apr 2023 · FDA Enforcement Report
Fast Acting Earwax Removal System (carbamide peroxide), 5% Drops recalled
Pharma Nobis is recalling Fast Acting Earwax Removal System (carbamide peroxide), 5% Drops per, distributed nationwide in the US. The recall was initiated on 6 Apr 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0537-2023
- FDA event ID
- 92080
- Recalling firm
- Pharma Nobis, Texarkana, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Apr 2023
- FDA classified
- 14 Apr 2023
- Reported
- 26 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 6 Apr 2023 | Recall initiated by company | |
| 14 Apr 2023 | Classified by FDA | +8 days |
| 26 Apr 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Stores named: CVS
Questions about this recall
Is Fast Acting Earwax Removal System (carbamide peroxide), 5% Drops per recalled?
Yes. Pharma Nobis recalled Fast Acting Earwax Removal System (carbamide peroxide), 5% Drops per on 6 Apr 2023. The recall is Class II and its status is Ongoing. Recall number D-0537-2023.
Why was it recalled?
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Which lots are affected?
Lots: A70293, A70294, A70295, Exp. 12/2023; A70746, A70747, A70748, A70749, Exp. 01/2024; A73051, A73052, Exp. 05/2024
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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