ChemLifeIntel/Companies/DermaRite Industries, LLC

DermaRite Industries, LLC

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Showing 4 of 4 briefs on DermaRite Industries, LLC

REGULATORY INTELLIGENCE·Recall

FDA Initiates Class II Recall for DermaRite's KleenFoam Antimicrobial Foam Soap Over CGMP Deviation

DermaRite Industries, LLC faces an FDA Class II recall for 15,267 cartridges of KleenFoam Antimicrobial Foam Soap (Chloroxylenol 0.5%). This action stems from a CGMP deviation at its North Bergen, NJ facility, where other products were found contaminated. Procurement and regulatory teams must assess supply chain continuity and quality assurance protocols for similar products.

90-Day Activity

DermaRite Industries, LLC

CMCatherine Morrow· Senior Regulatory Intelligence Analyst

2025-11-26

REGULATORY INTELLIGENCE·Recall

DermaRite Industries Recalls DermaFungal Cream Over CGMP Deviation and Contamination Risk

DermaRite Industries, LLC has initiated a nationwide Class II recall (D-0162-2026) for its DermaFungal Antifungal Cream containing 2% Miconazole Nitrate. The recall, impacting 1,480 packets, stems from a Current Good Manufacturing Practice (CGMP) deviation at its North Bergen, NJ facility, where other products were found contaminated. This event underscores critical supply chain vulnerabilities for procurement and regulatory teams sourcing topical antifungal agents, necessitating immediate risk assessment and potential diversification strategies to mitigate disruption.

90-Day Activity

DermaRite Industries, LLCDermaFungal, Antifungal Cream with 2% Miconazole NitrateHSN 3004.90

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2025-11-26

REGULATORY INTELLIGENCE·Recall

DermaRite Industries Initiates Class II Recall of McKesson Skin Protectant Due to CGMP Deviations and Contamination

DermaRite Industries, LLC has initiated a Class II recall for McKesson Skin Protectant, Lanolin USP, citing Current Good Manufacturing Practice (CGMP) deviations. Products manufactured at its North Bergen, NJ facility were found to be contaminated, posing a significant risk to supply chains. Procurement and regulatory teams must assess immediate inventory impacts and re-evaluate supplier quality oversight.

90-Day Activity

DermaRite Industries, LLCSkin Protectant

CMCatherine Morrow· Senior Regulatory Intelligence Analyst

2025-11-26

REGULATORY INTELLIGENCE·Recall

DermaRite Industries Faces Class I Recall for DermaSarra External Analgesic Due to Burkholderia cepacia Contamination

DermaRite Industries, LLC initiated a Class I recall (D-0611-2025) for 249 bottles of DermaSarra External Analgesic (Camphor 0.5%) due to contamination with *Burkholderia cepacia*. This nationwide recall, impacting Lot #: 40187.2, signals critical quality control failures. Procurement and regulatory teams must assess supply chain risks and ensure robust microbial testing protocols for non-sterile drug products to mitigate patient safety threats.

90-Day Activity

DermaRite Industries, LLC

PSPriya Subramaniam· Intelligence Analyst

2025-09-10 Recall