Drug Enforcement D-0537-2023

CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.

Status

Ongoing

Classification

Class II

Report Date

April 26, 2023

Termination Date

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Product Information

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.
Product quantity
69,615 bottles
Reason for recall
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Pharma Nobis LLC
Address
7400 Alumax Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0537-2023
Event ID
92080
Recall initiation date
April 6, 2023
Center classification date
April 14, 2023
Code info
Lots: A70293, A70294, A70295, Exp. 12/2023; A70746, A70747, A70748, A70749, Exp. 01/2024; A73051, A73052, Exp. 05/2024
More code info
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