Hospira Inc. is recalling 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80 because vials may be contaminated with particulate matter. Stainless steel manufacturing equipment has been identified as the source.
Particulate matter could act as emboli and impede blood flow, may cause mechanical damage to the body, and may escalate damage through the Systemic Inflammatory Response Syndrome, according to Hospira.
The at-risk lots were dispensed between July 2009 and October 2009, and no other lots are affected by this recall. Affected vials should be quarantined and Stericycle should be called at 866-654-0725 to arrange for the return of these products. Hospira has begun to ship replacement product.
For medical inquiries, contact Hospira Medical Communications at 800-615-0187. Adverse reactions may be reported to the FDA’s MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, or on the MedWatch Web site at www.fda.gov/medwatch.
Contact Hospira Customer Care at 877-946-7747 for further details.
Particulate matter could act as emboli and impede blood flow, may cause mechanical damage to the body, and may escalate damage through the Systemic Inflammatory Response Syndrome, according to Hospira.
The at-risk lots were dispensed between July 2009 and October 2009, and no other lots are affected by this recall. Affected vials should be quarantined and Stericycle should be called at 866-654-0725 to arrange for the return of these products. Hospira has begun to ship replacement product.
For medical inquiries, contact Hospira Medical Communications at 800-615-0187. Adverse reactions may be reported to the FDA’s MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, or on the MedWatch Web site at www.fda.gov/medwatch.
Contact Hospira Customer Care at 877-946-7747 for further details.
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