FDA Recall D-0598-2024

Brands International Corporation

Class II Ongoing 703 days on record

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

Product

Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case, Manufactured By:/Fabrique Par: , Brands International Corp., Newmarket, ON, L3X 2S2, Made in Canada.

Lot / code: Lot# 24092009, Exp 03/27; 24094010, Exp 04/27

Quantity: 120,319 bottles

Reason for recall

Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination

Recall record

Recall number: D-0598-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: USA nationwide.
Recall initiated: 2024-06-10
Classified by FDA Center: 2024-07-12
FDA published: 2024-07-24
Recalling firm: Brands International Corporation

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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