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Recall Observatory FDA recall evidence

Drug 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

D-0205-2025

November 13, 2024

Class II

Product summary

Firm
Brands International Corporation
Event
Event 95655
Status
Ongoing
Classification
Class II
Quantity
unknown
Official record key
drug-enforcement:D-0205-2025

Official wording

Reason: CGMP Deviations: lack of adequate release testing.

Code information: 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.

Distribution pattern: Nationwide USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations