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Category Archives: Uncategorized
Valproate Products Drug Safety Communicaton
Valproate Products: Drug Safety Communicaton – Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy) Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics AUDIENCE: OBGYN, … Continue reading
MedWatch February 2011 Safety Labeling Changes posting includes 53 products
The MedWatch February 2011 Safety Labeling Changes posting includes 53 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE. The “Summary Page” provides a listing of drug … Continue reading
Posted in FDA 2011, Uncategorized
Tagged FDA notice, FDA warning, February 2011, safety label changes
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Davol XenMatrix Surgical Graft: Class I Recall – Elevated Endotoxin Levels
Davol XenMatrix Surgical Graft: Class I Recall – Elevated Endotoxin Levels AUDIENCE: Risk Manager, Surgery ISSUE: FDA notified healthcare professionals that several lots of XenMatrix Surgical Graft have been found to have elevated endotoxin levels. Endotoxins (pyrogens) are substances found in … Continue reading
Posted in FDA 2011, Uncategorized
Tagged Class 1 Recall, FDA notice, FDA recall, FDA warning, XenMatrix surgical Graft
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