FDA Initiates Class II Recall for EnviroServe Chemicals' EnviroClean Hand Sanitizer Due to CGMP Deviations
EnviroServe Chemicals Inc. has initiated a Class II recall of 120 bottles of EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v) due to Current Good Manufacturing Practice (CGMP) deviations. This action, initiated September 18, 2024, by the FDA, impacts a single North Carolina distributor. Procurement and regulatory teams must assess supplier quality systems rigorously, especially for essential over-the-counter products like hand sanitizers.
FDA Initiates Class II Recall for EnviroServe Chemicals' EnviroClean Hand Sanitizer
The U.S. Food and Drug Administration (FDA) has initiated a Class II recall, identified as D-0667-2024, for EnviroClean Hand Sanitizer Gel manufactured by EnviroServe Chemicals Inc. This voluntary, firm-initiated recall commenced on September 18, 2024, and was classified by the FDA on September 24, 2024. The affected product is EnviroClean Hand Sanitizer Gel, containing 70% v/v isopropyl alcohol, packaged in 473 mL (16 fl. oz.) bottles. Specifically, the recall targets Lot #: 042224-L1, with an expiration date of April 22, 2025, and NDC 76563-3010-1. For procurement directors and supply chain VPs, this event underscores the critical importance of continuous quality oversight, even for seemingly commoditized products. While the recalled quantity is relatively small—120 bottles—and distribution was limited to a single distributor in North Carolina, the underlying cause, Current Good Manufacturing Practice (CGMP) deviations, signals potential systemic quality control vulnerabilities. Regulatory affairs heads must recognize that CGMP non-compliance, regardless of scale, can lead to product integrity issues and regulatory enforcement, impacting brand reputation and market access. This specific recall, originating from EnviroServe Chemicals Inc.'s facility at 603 S Wilson Ave, Dunn, NC, 28334-5832, necessitates a review of supplier audit protocols for similar over-the-counter (OTC) drug products.
Business Impact of CGMP Deviations in OTC Drug Manufacturing
The identification of Current Good Manufacturing Practice (CGMP) deviations as the reason for this recall carries significant commercial implications for companies operating in the chemical and life sciences sectors. For business development executives, CGMP non-compliance can severely impact market opportunities, especially in highly regulated markets like the United States. A recall, even of a Class II nature, can erode customer trust and lead to increased scrutiny from regulatory bodies, potentially affecting future product approvals or market expansion. Procurement directors sourcing isopropyl alcohol-based sanitizers or other OTC drug products must view this incident as a critical data point in their supplier risk assessments. The absence of robust CGMP adherence at a manufacturing facility, such as EnviroServe Chemicals Inc. in Dunn, NC, indicates a failure to meet fundamental quality and safety standards. This translates directly into supply chain risk, as products from non-compliant facilities may face future recalls, import alerts, or even manufacturing suspensions. Regulatory affairs heads should ensure that their internal quality management systems and supplier qualification programs include rigorous, ongoing audits to verify CGMP compliance, thereby safeguarding product quality and minimizing regulatory exposure across their entire portfolio.
EnviroServe Chemicals Inc.: Operational Context and Future Regulatory Scrutiny
EnviroServe Chemicals Inc., located at 603 S Wilson Ave, Dunn, NC, operates as a manufacturer within the chemical and life sciences industry. This recall of their EnviroClean Hand Sanitizer Gel highlights the ongoing regulatory responsibilities associated with producing drug products, even those considered over-the-counter. While the immediate distribution of the recalled product was confined to one distributor within North Carolina, the FDA's classification of the event as a Class II recall indicates that the use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. For regulatory affairs teams, the ongoing status of this recall (as of October 2, 2024) means continued monitoring and potential follow-up actions by the FDA. Manufacturers with CGMP deviations are typically required to implement corrective and preventive actions (CAPA) to address the root causes of non-compliance. While specific details of EnviroServe Chemicals Inc.'s remediation plan are not public, the event serves as a reminder for all manufacturers that maintaining a state of control over manufacturing processes is paramount. Business development executives considering partnerships or sourcing from new suppliers should conduct thorough due diligence, including reviewing regulatory history and quality system maturity, to mitigate risks associated with compliance failures.