Over 67,000 cases of deodorants sold at Walmart, Amazon recalled due to 'cGMP deviations'. What is it?

Time of India

6 days ago

Over 67,000 cases of three types of Power Stick deodorant sold at Walmart, Amazon and Dollar Tree have been recalled due to 'cGMP deviations". This means the product did not meet manufacturing regulations by the Food and Drug Administration (FDA).
On Thursday, the US Food and Drug Administration announced a nationwide recall of some
Power Stick deodorants
, manufactured by
A.P. Deauville
.
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The recall was voluntary and involves 21,265 cases of Power Stick for Her Roll-on Antiperspirant Deodorant Powder Fresh; 22,482 cases of Power Stick Invisible Protection Roll-On Antiperspirant Deodorant Spring Fresh; and 23,467 cases of Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant Deodorant.
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The FDA states that recall is due to 'cGMP deviations.' The agency's website notes that CGMP stands for 'Current Good Manufacturing Practice' and these regulations 'make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.'
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The antiperspirants were distributed nationwide and sold at Walmart, Amazon and Dollar Tree. A.P. Deauville also makes shampoo, conditioner, lotion, body wash and facial wipes.
What is CGMP?
For the recall, the FDA enforcement reported
cGMP deviations
, which listed failures in adhering to current good manufacturing practices as the primary reason. According to FDA, the main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMP) regulations for human pharmaceuticals.
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"CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards," FDA says.
Why is CGMP so important?
A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work. While CGMP requires testing, testing alone is not adequate to ensure quality, the FDA says. In most instances testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing.
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Therefore, it is important that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing process at every step. However, it is important to note that no harmful substance was found in those products.
"If a company is not complying with CGMP regulations, any drug it makes is considered 'adulterated' under the law. This kind of adulteration means that the drug was not manufactured under conditions that comply with CGMP. It does not mean that there is necessarily something wrong with the drug," according to FDA.