URGENT: VOLUNTARY MARKET WITHDRAWAL | |
Initiated by : Octapharma USA Inc. Event Id : 162 Event Date : 04-25-2016 |
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Reason | OCTAGAM 5% [IMMUNE GLOBULIN INTRAVENOUS (human)] LIQUID PREP This withdrawal of one lot of Octagam 5% is being conducted as a precautionary measure due to an increased number of reports of hypersensitivity reactions such as rashes or urticaria and/or wheezing. |
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Action | 1) Please check all Octogam 5% labels for presence of affected lot (K551A441). 2) Do not infuse this product. Return affected withdrawn lots to the point of purchase to receive replacement product. 3) Contact your physician if you have medical questions. 4) For clinical questions about Octagam 5%, contact Dipen Patel, Head, US Drug Safety Unit at 201 604 1137 |
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Other Information | If you need assistance, please call Sedgwick, Inc. at 1-888-UPDATE-U. |