REGULATORY INTELLIGENCE·Warning Letter
Teva Pharmaceuticals Recalls 1.46 Million Cephalexin Bottles Over CGMP Deviations
Teva Pharmaceuticals USA, Inc. initiated a Class II voluntary recall (D-0013-2021) for 1,467,535 bottles of Cephalexin for Oral Suspension due to Current Good Manufacturing Practice (CGMP) deviations. This event, now terminated, highlights critical quality control risks where active ingredient levels were potentially outside specification limits. Procurement and regulatory teams must scrutinize supplier quality systems, even for generic products, to mitigate supply chain disruptions and ensure patient safety.
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