FDA Recalls, Market Withdrawals & Safety AlertsOther

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion

Recall fda-alert:2026-09-21:Par Pharmaceutical:Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous InfusionPublished 2026-09-21Company Par Health
ReasonPresence of particulate matter identified as cellulose or stopper material
DistributionThis field was not provided in the official notice. Please confirm in the original notice.
Code informationThis field was not provided in the official notice. Please confirm in the original notice.
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Official-information notice
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Official record details

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Recall number

fda-alert:2026-09-21:Par Pharmaceutical:Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion

Classification

Other

Published

2026-09-21

Recalling firm

Par Health

Product description

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion

Product code

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Code information

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Product quantity

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Distribution

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Reason for recall

Presence of particulate matter identified as cellulose or stopper material

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Last synchronized: 2026-09-21. Foods Recall does not replace agency guidance.