FDA Class II Recall: A.P. Deauville's Antiperspirant Pulled Over CGMP Deviations
A.P. Deauville, LLC has initiated a U.S. nationwide Class II recall for 21,265 cases of its Power Stick for her Roll-On Antiperspirant Deodorant due to Current Good Manufacturing Practice (CGMP) deviations. This action, impacting a key over-the-counter product containing Aluminum Sesquichlorohydrate, signals significant regulatory compliance risks for procurement and regulatory affairs teams. The ongoing recall underscores the critical need for robust quality assurance.
FDA Class II Recall: A.P. Deauville's Antiperspirant Pulled Over CGMP Deviations
A.P. Deauville, LLC, based in Easton, PA, United States (postal code 18040-9285), has voluntarily initiated a Class II recall, designated D-0548-2025, for its Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent. This significant regulatory action, initiated on July 10, 2025, stems from identified Current Good Manufacturing Practice (CGMP) deviations at the firm’s operations. The recalled product, an over-the-counter (OTC) human drug, contains Aluminum Sesquichlorohydrate as its active pharmaceutical ingredient (API) and is identified by NDC# 42913-038-00 and UPC Code 815195019313. A total of 21,265 cases are affected, distributed U.S. Nationwide, impacting a substantial volume of consumer product. This event signals a critical failure in quality systems that directly affects product integrity and market availability. For procurement directors, this means an immediate disruption in supply for this specific product line and a heightened need to verify the quality assurance processes of all suppliers, particularly those manufacturing OTC drug products. Regulatory affairs heads must note the 'Ongoing' status of this recall, indicating continued FDA oversight and potential for further compliance actions.
Commercial Implications of CGMP Non-Compliance for OTC Drug Manufacturers
The CGMP deviations cited as the reason for A.P. Deauville’s recall of Power Stick for her Roll-On Antiperspirant Deodorant carry substantial commercial implications for the company and the broader OTC drug market. For business development executives, this recall represents a significant blow to brand reputation and market trust for A.P. Deauville, LLC. The generic name, Aluminum Sesquichlorohydrate, is a common active ingredient in antiperspirants, making the manufacturing quality of such widely used products paramount. The recall of 21,265 cases across the U.S. nationwide distribution pattern indicates a widespread issue that will require extensive remediation and potential market re-entry challenges. Supply chain VPs must recognize that CGMP non-compliance can lead to costly product withdrawals, inventory write-offs, and strained relationships with retailers and distributors. Furthermore, the FDA’s classification of this as a Class II recall suggests that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. This level of risk necessitates prompt and thorough corrective actions, impacting A.P. Deauville's operational continuity and financial performance.
Navigating Supply Chain Risks and Future Regulatory Scrutiny
The ongoing Class II recall by A.P. Deauville, LLC due to CGMP deviations necessitates immediate attention from supply chain VPs and regulatory affairs heads. The specific lot numbers identified—032026B011, 032226B031, 051626C241, 061526C882, 071226D371, 071226D381, 082526E341, 082826E402—underscore the need for precise inventory management and traceability throughout the distribution network. For procurement directors, this event highlights the critical importance of rigorous supplier qualification and ongoing auditing processes to prevent similar disruptions. Relying solely on a single supplier for key OTC drug components or finished products, such as those containing Aluminum Sesquichlorohydrate, exposes businesses to significant risk. The FDA's continued oversight, indicated by the 'Ongoing' status of the recall, means A.P. Deauville, LLC will face intensified scrutiny regarding its quality systems and manufacturing controls. Regulatory affairs teams must prepare for potential follow-up inspections, requests for detailed corrective and preventive action (CAPA) plans, and the possibility of further enforcement actions if the underlying CGMP deficiencies are not adequately addressed. Proactive engagement with the FDA and transparent communication will be crucial for A.P. Deauville to mitigate long-term regulatory and commercial impacts.