FDA Drugs (New Approvals & NDA)Original article
Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter
RegulatoryDexmedetomidine HCl in 0.9% Sodium Chloride InjectionNegative
AI Analysis
Summary
Par Health issued a voluntary nationwide recall of two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL due to the presence of particulate matter identified as cellulose or stopper material. The recall is at the hospital level.
Outcome Details
Voluntary nationwide recall of two lots due to presence of particulate matter (cellulose or stopper material)
Importance:4/10
Sentiment:
-0.70
recallproduct_safetyparticulate_matterinjectionhospital_level
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Published by FDA Drugs (New Approvals & NDA) on September 21, 2026 7:37 PM