REGULATORY INTELLIGENCE·Warning Letter
Nostrum Laboratories Inc. Faces FDA Scrutiny Over Theophylline CGMP Deviations and Labeling Errors
Nostrum Laboratories Inc. initiated a Class II recall of Theophylline (Anhydrous) Extended-Release Tablets due to critical CGMP deviations and incorrect labeling. This event highlights significant quality control failures at their Kansas City, MO facility, impacting supply chain reliability. Decision-makers must assess supplier risk and reinforce robust quality assurance protocols to mitigate similar disruptions and ensure regulatory compliance.
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