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SafetyAlerts
November 15, 2002

Fresenius Kabi Clayton Has Recalled Intralipid

(SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
Intralipid 20% I.V. Fat Emulsion, For Intravenous Use,
(Soybean Oil 20.0g, Phospholipids 1.2g, Glycerin, USP 2.25g) 500 mL bottles, Rx only. Recall # D-049-3.

CODE
NR66160, NR66161, NR66162, NR66163, NR66164, NR66166,
NR66169, NR66170, NR66171.

RECALLING FIRM/MANUFACTURER
Fresenius Kabi Clayton L.P., Clayton, NC, by letter on July 9, 2002. Firm initiated recall is ongoing.

REASON
Mislabeling: bottles incorrectly labeled as Intralipid 30% rather than correctly as Intralipid 20%.

VOLUME OF PRODUCT IN COMMERCE
30,115 units.

DISTRIBUTION
IL.

 
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.