REGULATORY INTELLIGENCE·Warning Letter
FDA Class II Recall: The Harvard Drug Group LLC's Omega-3-Acid Ethyl Esters Capsules Fail Quality Specifications
The Harvard Drug Group LLC has initiated a Class II recall for Omega-3-Acid Ethyl Esters Capsules due to out-of-specification Loss on Drying. This nationwide recall, impacting 2,238 cartons, necessitates immediate supply chain review and quality assurance reassessment for procurement directors and regulatory affairs heads, highlighting critical compliance risks for this essential cardiovascular therapy.
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