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DICYCLOMINE HYDROCHLORIDE

HIGH RISKHQ: — · Private · Founded —
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INTELLIGENCE

Showing 2 of 2 briefs on DICYCLOMINE HYDROCHLORIDE
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.

90-Day Activity
DICYCLOMINE HYDROCHLORIDEMeclizine Hydrochloride
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2026-04-01
REGULATORY INTELLIGENCE·Warning Letter

Dicyclomine Hydrochloride Recall Signals Critical CGMP Gaps for Actavis, Teva, and Cardinal Healthcare

A Class II recall of Dicyclomine Hydrochloride Tablets, USP 20 mg, initiated by Cardinal Healthcare for Teva Pharmaceuticals USA, highlights critical CGMP deviations. Products were exposed to temperatures outside labeled storage conditions, raising concerns about product integrity. This event underscores the urgent need for procurement and regulatory teams to reassess quality oversight across complex pharmaceutical supply chains.

90-Day Activity
DICYCLOMINE HYDROCHLORIDEDicyclomine Hydrochloride
PSPriya Subramaniam· Intelligence Analyst
2024-01-03