REGULATORY INTELLIGENCE·Warning Letter
Akorn's Myorisan Recall: Class II Mispackaging Exposes Critical Pharmaceutical Quality Control Gaps
Akorn, Inc. initiated a Class II recall for 4,206 boxes of MYORISAN (isotretinoin capsules, 20mg) due to unit dose mispackaging, where 40mg blister cards were found in 20mg cartons. This event, terminated in August 2022, underscores persistent quality control challenges in pharmaceutical manufacturing, impacting patient safety and supply chain integrity for procurement and regulatory leaders.
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