ChemLifeIntel/Companies/EnviroServe Chemicals Inc.

EnviroServe Chemicals Inc.

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INTELLIGENCE

Showing 3 of 3 briefs on EnviroServe Chemicals Inc.

REGULATORY INTELLIGENCE·Warning Letter

JB Chemicals' Enalapril Maleate Recall Signals Heightened FDA Scrutiny on Impurity Control

JB Chemicals and Pharmaceuticals Ltd initiated a Class II recall for Enalapril Maleate Tablets due to organic impurity failures, impacting 675 bottles distributed nationwide in the USA. This event, originating from Unique Pharmaceutical Laboratories in Mumbai, India, underscores critical quality control deficiencies. Procurement and regulatory teams must assess supply chain stability and identify alternative sources for this essential cardiovascular medication to mitigate disruption risks.

90-Day Activity

EnviroServe ChemicalsEnalapril MaleateHSN 2933.39

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2026-05-13▲ Trending signal

REGULATORY INTELLIGENCE·Recall

FDA Class III Recall: JB Chemicals' Cetirizine Hydrochloride Tablets Affected by Imprinting Error

JB Chemicals and Pharmaceuticals Ltd has initiated a Class III recall of 13,440 bottles of Cetirizine Hydrochloride Tablets USP 10 mg due to incorrect tablet imprinting. Distributed U.S. nationwide by Rising Pharma Holdings, Inc., this event highlights critical quality control gaps at the Mumbai, India manufacturing facility, impacting supply chain integrity and demanding immediate action from procurement and regulatory teams.

90-Day Activity

EnviroServe ChemicalsCetirizine Hydrochloride

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2025-10-29

REGULATORY INTELLIGENCE·Recall

FDA Initiates Class II Recall for EnviroServe Chemicals' EnviroClean Hand Sanitizer Due to CGMP Deviations

EnviroServe Chemicals Inc. has initiated a Class II recall of 120 bottles of EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v) due to Current Good Manufacturing Practice (CGMP) deviations. This action, initiated September 18, 2024, by the FDA, impacts a single North Carolina distributor. Procurement and regulatory teams must assess supplier quality systems rigorously, especially for essential over-the-counter products like hand sanitizers.

90-Day Activity

EnviroServe ChemicalsEnviroClean Hand Sanitizer GelHSN 3808.94

CMCatherine Morrow· Senior Regulatory Intelligence Analyst

2024-10-02