REGULATORY INTELLIGENCE·Recall
ARG Laboratories Initiates Nationwide Class II Recall of Pain Wizard Due to Active Ingredient Out-of-Specification and Violative Excipient Use
ARG Laboratories, Inc. has initiated a Class II nationwide recall for 3,504 units of its Pain Wizard roll-on. This action stems from the product being out of specification for active ingredients Camphor and Menthol, alongside the use of a violative grade of propylene glycol. Procurement and quality assurance teams must scrutinize supplier quality controls to mitigate similar risks and ensure compliance with FDA standards for excipients and active pharmaceutical ingredients.
90-Day Activity
ARG Laboratories,HSN 2905.32HSN 2906.11HSN 3301.29
PSPriya Subramaniam· Intelligence Analyst2024-06-05