Recall of Argatroban Injection Due to Particulate Matter
Par Health USA, LLC has announced a voluntary nationwide recall of twenty-two lots of Argatroban Injection to the hospital and user level. The recall was initiated following the detection of particulate matter identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel.
Administration of an affected product carries a reasonable probability of causing serious and life-threatening adverse consequences. These risks include pulmonary emboli, blood vessel occlusions leading to tissue death and organ damage, and inflammation of vein walls that may promote clotting. No adverse events related to this recall have been reported to date.
Distributors and hospitals possessing the impacted product are advised to immediately stop use and distribution, notify any further recipients, and arrange for product returns through Inmar, Inc. Clinicians should check their stock for the specified lots and follow institutional recall protocols.
Key points
- Twenty-two lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) are being recalled.
- Particulate matter found includes cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel.
- Risks include pulmonary embolism, vascular occlusion, tissue necrosis, organ damage, and vessel inflammation.
- No adverse events have been reported to the company so far.
What it means for you
Clinicians and pharmacists should immediately inspect their inventory for the recalled lots of Argatroban Injection and halt their use and distribution. Because this is an FDA safety alert, healthcare professionals in Pakistan should check with the Drug Regulatory Authority of Pakistan (DRAP) to determine if these specific products or batches are registered, imported, or available locally, and adhere to any local regulatory guidance.
Par Health Issues Voluntary Nationwide Recall of Argatroban 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.