Par Health Recalls Two Lots of Dexmedetomidine HCl Injection
Par Health has issued a voluntary recall to the hospital level for two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection (400 mcg/100 mL). The action was initiated due to the discovery of particulate matter identified as cellulose or stopper material within the solution.
Administration of an intravenous product containing particulate matter carries a reasonable probability of severe health risks, including pulmonary emboli, vascular occlusions leading to tissue death and organ damage, and vessel wall inflammation. To date, the company has not received any reports of adverse events linked to this recall.
Key points
- Recalled product: Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL for intravenous infusion.
- Affected lots: Lot 87558 (expiration 02/2027) and Lot 88802 (expiration 04/2027).
- Reason for recall: Presence of particulate matter identified as cellulose or stopper material.
- Potential risks include pulmonary emboli, blood vessel occlusions, and phlebitis.
What it means for you
Clinicians and hospital pharmacists should immediately check their inventory, discontinue the use of the affected lots, and halt any further distribution. Since this is an FDA safety alert from an overseas market, clinicians and pharmacists in Pakistan should check with DRAP for local availability and guidance regarding similar products.
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
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.