REGULATORY INTELLIGENCE·Warning Letter
FDA Cites Quality Failures for Meclizine Hydrochloride: Class II Recall Signals Heightened Regulatory Risk
The FDA's focus on quality control is underscored by a Class II recall of Meclizine Hydrochloride Tablets, USP 12.5 mg, by Amerisource Health Services LLC, linked to failed tablet specifications from American Health Packaging. This event signals critical supply chain vulnerabilities and necessitates immediate action from procurement and regulatory teams to mitigate disruption and ensure compliance.
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