Voluntary Recall of Liposyn and Propofol Issued
Hospira, a global specialty pharmaceutical company, has notified the FDA of a voluntary recall of some of its products due to a manufacturing defect. Some of the vials of the following products may contain particulates matter from some of the stainless steel equipment used in the manufacturing process. The presence of these particulates may turn these into defective drugs. The specific products affected by the recall include 85 lots of the following:
- Liposyn II 10%
- Liposyn II 20%
- Liposyn III 10%
- Liposyn III 20%
- Liposyn III 30%
- Propofol Injectible Emulsion 1%
The affected lots were distributed between July 2009 and October 2009. There are no other products affected by this recall.
Liposyn is an intravenous fat emulsion used to increase fat levels for people who are unable to process fat due to illness. Lyposin provides calories and nutrients for patients who are unable to eat and must be fed through an IV.
Propofol is a short acting sedation agent that is administered intravenously. It is used for mechanically ventilated patients and general anesthesia.
The body is unable to dissolve the particulates found in the recalled products. Contaminated product may cause the following health problems:
- Systemic Inflammatory Response Syndrome (SIRS)
The resultant restrictions in blood supply may lead to:
- Respiratory failure
- Kidney failure
- Liver failure
- Heart attach
Any adverse reactions resulting from these recalled products should be reported to the FDAs MedWatch Program at 1-800-FDA-1088. To find out more about this recall, and how to return products, please contact Hospira Customer Care at 1-877-946-7747.
If you or a loved one has suffered personal injury or died because of contaminated Liposyn, please contact the experienced drug litigation attorneys at Schlichter, Bogard & Denton, LLP.