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City Richmond / Reference / / Company Assessments Reckitt Benckiser Pharmaceuticals Inc. / Reckitt Benckiser Healthcare / CIII Buprenorphine (opioid partial agonist-antagonist) Reckitt Benckiser Pharmaceuticals Inc. / Reckitt Benckiser Pharmaceuticals Inc. / / Country United States / United Kingdom / / Event Product Issues / FDA Phase / Product Recall / Person Communication and Meetings / / Facility I store SUBUTEX / Store SUBUTEX / Midlothian Turnpike / / IndustryTerm retail pharmacies / healthcare professionals / heavy machinery / / MedicalCondition loss of consciousness / drug addiction / Allergic reaction / fewer withdrawal symptoms / Headache / hives / hallucinations / coma / nausea / drowsiness / serious withdrawal symptoms / diarrhea / normal / runny nose / Constipation / infections / cramps / wheezing / head injury / insomnia / hypothyroidism / vomiting / pain / Drug withdrawal syndrome / muscle aches / dizziness / withdrawal symptoms / rash / / MedicalTreatment counseling / behavioral therapy / / Organization FDA / National Technical Information Service / / / Position Pharmacist / Physician / Introductory Pharmacist / / Product A. Medication / symptoms / signs / SUBUTEX / Put / Sublingual Tablet / mannitol / Opioid / Drug / Medication Guide / This Medication / K30 / SUBUTEX Tablet / SUBUTEX® (buprenorphine) / REMS / / ProvinceOrState Virginia / / PublishedMedium the Medication Guide / /
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Initial REMS Approval: December[removed]NDA[removed]SUBUTEX® (buprenorphine) sublingual tablet CIII Buprenorphine (opioid partial agonist-antagonist)