Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deodorant Net Wt 2.6 oz (73g) NDC# 41595-5547-1 UPC 8 83484 31020 5 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations; product intended for quarantine was inadvertently distributed
Reason cGMP deviations
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Reason Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
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