Glenmark Recalls 1.5 Million ADHD Medication Bottles in U.S

quick Summary

• Glenmark Pharmaceuticals is recalling nearly 15 lakh bottles of a generic ADHD medication in teh U.S.
• The recalled medication, Atomoxetine capsules, comes in strengths from 10 mg to 100 mg.
• The recall is due to “CGMP Deviations” and the presence of N-Nitroso Atomoxetine impurity above FDA limits.
• Glenmark Pharmaceuticals Inc,USA initiated a Class II recall on January 29.
• A Class II recall indicates potential temporary or medically reversible health consequences with remote chances of serious effects.

Indian Opinion Analysis

The recall by Glenmark Pharmaceuticals highlights the critical importance of adhering to Good Manufacturing practices (CGMP) in pharmaceutical production. This action serves as a reminder for Indian pharmaceutical companies about maintaining stringent quality control measures. Given India’s critically important role as a supplier in the global drug market, ensuring product safety and compliance with international standards is vital for sustaining trust and market position. Even though this incident involves temporary risks according to USFDA classification, it underscores their vigilance towards impurities even at low-risk evaluation levels.

Read More

!Representative Image