November 2024 FDA Recall Drug by Brands International Corporation
D-0205-2025 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Brands International Corporation on November 13, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0205-2025

Reason for Recall
CGMP Deviations: lack of adequate release testing.
Initiated
11-13-2024
Reported
01-29-2025
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95655
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Brands International Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 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.