ChemLifeIntel/Companies/Wells Pharma of Houston LLC

Wells Pharma of Houston LLC

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INTELLIGENCE

Showing 2 of 2 briefs on Wells Pharma of Houston LLC

REGULATORY INTELLIGENCE·Warning Letter

FDA Mandates Class II Recall for Wells Pharma's Fentanyl Citrate Due to cGMP Deviations, Highlighting Recurring Compliance Risks

Wells Pharma of Houston LLC faces an FDA Class II recall for fentaNYL Citrate injectable solution due to cGMP deviations, impacting nationwide U.S. distribution. This marks a concerning pattern, following a similar recall for Ketamine HCl. Procurement and regulatory teams must assess supply chain continuity for critical narcotics and scrutinize Wells Pharma's remediation efforts to mitigate future compliance risks and ensure patient safety.

90-Day Activity

Wells Pharma of Houston LLC

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2026-05-06 Warning Letter

REGULATORY INTELLIGENCE·Warning Letter

FDA Class II Recall: Wells Pharma's Ketamine HCl Injectable Solution Pulled Nationwide Over cGMP Deviations

Wells Pharma of Houston LLC has initiated a nationwide Class II recall for 4,975 syringes of Ketamine Hydrochloride Injectable Solution due to significant cGMP deviations. This action underscores critical supply chain vulnerabilities for essential medicines and demands immediate review by procurement and regulatory teams to mitigate disruption and ensure patient safety from this Houston-based manufacturer.

90-Day Activity

Wells Pharma of Houston LLCDexmedetomidine Hydrochloride In 0.9% Sodium Chloride

CMCatherine Morrow· Senior Regulatory Intelligence Analyst

2026-05-06