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The U. Companies who fail to correct the violations, as outlined in the warning letters, may be subject to enforcement action, including product seizure or injunction. Consumers who use these products take significant risk with their lives. The new warning letters are part of a comprehensive campaign to target illegal sales of unapproved opioids. The boxed warnings address risks including addiction, abuse, misuse, life-threatening respiratory depression breathing problems and neonatal opioid withdrawal syndrome withdrawal symptoms in newborn babies. In addition, when taken with other central nervous system depressants, including alcohol, their use may result in coma or death.
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