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|
 intravenous fat emulsion |
| Liposyn |
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Pharmaceutical
company:
Hospira
www.hospira.com |
NEW WARNING
The Food and Drug Administration (FDA) and Hospira, Inc. have notified health care professionals about the recall of 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30%. These products, which were distributed in July and October 2009 and begin with lot numbers 79 and 80, are being recalled because some of the containers may contain particulate matter. The particulate matter came from the stainless steel equipment used to manufacture these products. Because the particulates don't dissolve in the blood, they could act as emboli, impeding blood flow. Stroke, respiratory failure, kidney failure, liver failure, heart attack, or death may result from the impeded blood flow. Particulates may also mechanically damage the body and cause systemic inflammatory response syndrome.
Report any adverse events related to use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online, by phone at 1-800-332-1088, or by mailing the postage-paid FDA form 3500 or faxing it to 1-800-FDA-0178.
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