FDA Recall D-0205-2025

Brands International Corporation

Class II Ongoing 547 days on record

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

Product

Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3

Lot / code: Lots: 23319025, 23318024, 23313023, 23311022, 23310021, 23222021, 23220020, 23215019, 23215018, 23214017, 23213016, 23208015, 2313014, 2312213, 2312212, 2312111, 2312110, 2311709, 2311708, 2311607, 2311506, 2311405, 2307904, 23073003, 23072002, 2306901 and 24135003. All expiration dates within expiry.

Quantity: unknown

Reason for recall

CGMP Deviations: lack of adequate release testing.

Recall record

Recall number: D-0205-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide USA
Recall initiated: 2024-11-13
Classified by FDA Center: 2025-01-17
FDA published: 2025-01-29
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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