REGULATORY INTELLIGENCE·Warning Letter
FDA Class II Recall: Ascend Laboratories' Olmesartan Medoxomil Due to Unapproved API Source Change
Ascend Laboratories LLC initiated a Class II recall of Olmesartan Medoxomil Tablets 20 mg due to cGMP deviations. The product was released with an unapproved alternate API source, highlighting critical regulatory and supply chain risks. This event underscores the imperative for robust change control and validated API sourcing strategies to maintain market access and patient safety.
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