| Document Date: 2014-12-16 14:32:33
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City Reference / / Company Reckitt Benckiser Pharmaceuticals Inc. / Cortex Pharmaceuticals Inc. / / Event Product Recall / Product Issues / FDA Phase / / Facility Store SUBOXONE / / IndustryTerm buprenorphine sublingual solutions / machinery / mg solution / hazardous machinery / sublingual solution / buprenorphine products / administered product / fixed-dose combination product / buprenorphine solution / combination product / fixed combination product / buprenorphine product / / MedicalCondition anaphylactic shock / myoclonus / headache / CNS Depression / neonatal withdrawal syndrome / hives / cytolytic hepatitis / coma / dysfunction / apnea / respiratory depression / nausea / prostatic hypertrophy / hepatitis C / hepatitis B / hyperhidrosis / hepatic necrosis / withdrawal syndrome / bradycardia / hypersensitivity / Addison's disease / Diarrhea / Hepatitis / constipation / pruritus / hepatorenal syndrome / Whole Abscess / Flu Syndrome / head injury / insomnia / toxic psychoses / bronchospasm / urethral stricture / marked and intense opioid withdrawal syndrome / hypothyroidism / Chills / Carcinogenesis / chronic obstructive pulmonary disease / acute hepatitis / hepatic encephalopathy / increased CNS depression / chronic administration / Insomnia N / Orthostatic Hypotension / vomiting / pain / hypertonia / neonatal tremor / fatal / respiratory depression / acute alcoholism / myxedema / hepatic failure / Allergic Reactions / Drug Abuse / significant respiratory depression / respiratory depression / infection / delirium tremens / Dizziness / opioid withdrawal syndrome / Depression / miosis / angioneurotic edema / cor pulmonale / / MedicalTreatment counseling / psychotherapy / pharmacotherapy / / Organization Chronic administration / DOSAGE AND ADMINISTRATION / FDA / / / Position Secretary of Health / physician / General / / Product signs / SUBUTEX / Neonatal / Operate Machinery SUBOXONE / Sublingual Tablets / 5.9 Neonatal Withdrawal Neonatal / Use / naloxone / SUBOXONE / General Precautions SUBOXONE / Opioid / Administer SUBOXONE / syndrome / Store SUBOXONE / patients / machinery / Hepatic Function / / Technology drug screening / Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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• A marked and intense opioid withdrawal syndrome is highly likely to occur with parenteral misuse of SUBOXONE sublingual tablet by individuals physically dependent on full opioid agonists or by sublingual administrat