Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON,
Summary
The FDA issued a Class II for Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Br by Brands International Corporation. Reason: CGMP Deviations: lack of adequate release testing..
Details
Source
Drug Recall
External ID
D-0205-2025
Action Date
2025-01-29
Status
Ongoing
Category
drug
Product Description
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 Info: 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 Affected: unknown
Reason for Recall
CGMP Deviations: lack of adequate release testing.
Distribution
Nationwide USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-13
Company
Newmarket
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 114 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Brands International Corporation has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Brands International Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Brands International Corporation have FDA actions?
Brands International Corporation has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0205-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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