Pharma Nobis LLC: Drug Recall

Recall #D-0537-2023 · 04/06/2023

Class II: Risk

Recall Details

Recall Number
D-0537-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Pharma Nobis LLC
Status
Ongoing
Date Initiated
04/06/2023
Location
Texarkana, TX, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
69,615 bottles

Reason for Recall

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.

Distribution Pattern

Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.