FDA Recall D-0537-2023

Pharma Nobis LLC · Texarkana, TX

Class II Ongoing 1134 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lots: A70293, A70294, A70295, Exp. 12/2023; A70746, A70747, A70748, A70749, Exp. 01/2024; A73051, A73052, Exp. 05/2024

Quantity: 69,615 bottles

Reason for recall

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

Recall record

Recall number: D-0537-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2023-04-06
Classified by FDA Center: 2023-04-14
FDA published: 2023-04-26
Recalling firm: Pharma Nobis LLC
Firm location: Texarkana, TX

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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