REGULATORY INTELLIGENCE·Recall
Nubratori, Inc. Initiates Class II Recall for Dexonto 0.4% Due to Critical Labeling Error
Nubratori, Inc. has initiated a Class II recall for its Dexonto 0.4% (dexamethasone sodium phosphate) solution due to an incorrect expiration date on outer packaging. This voluntary, firm-initiated action impacts 20 boxes distributed in PA and CA, highlighting the critical need for stringent labeling controls to prevent patient safety risks and ensure regulatory compliance.
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