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City Reference / Richmond / / Company Assessments Reckitt Benckiser Pharmaceuticals Inc. / Reckitt Benckiser Pharmaceuticals Inc. / / Country United States / / Event Product Issues / Product Recall / FDA Phase / Person Communication and Meetings / / Facility I store SUBOXONE / Store SUBOXONE / 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 / Put / Sublingual Tablet / mannitol / naloxone / SUBOXONE / Opioid / Drug / Medication Guide / SUBOXONE Tablet / CIII ® Buprenorphine / REMS / / ProvinceOrState Virginia / / PublishedMedium the Medication Guide / /
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Initial REMS Approval: December[removed]NDA[removed]SUBOXONE (buprenorphine and naloxone) sublingual tablet CIII