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Drug and Product Recall Information
Propofol Injectable Emulsion, 10mg/Ml.Recall
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PRODUCT: |
Lot #/Exp Dates |
NDC |
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PROPOFOL SDV 10MG/ML 100ML Single Vial |
31305429B 1/2011 31305430B 1/2011 31305324B 1/2011 |
00703 2859 01 Ind Vial |
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PROPOFOL SDV 10MG/ML 100ML 10 |
31305429B 1/2011 31305430B 1/2011 31305324B 1/2011 |
00703 2859 03 Pkg 10 Vial |
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PROPOFOL SDV 10MG/ML 50ML Single Vial |
31305431B 1/2011 |
00703-2858-01 Ind Vial |
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PROPOFOL SDV 10MG/ML 50ML 20 |
31305431B 1/2011 |
00703-2858-09 Pkg 20 Vial |
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PROPOFOL SDV 10MG/ML 20ML Single Vial |
31305323B 1/2011 |
00703-2856-01 Ind Vial |
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PROPOFOL SDV 10MG/ML 20ML 25 |
31305323B 1/2011 |
00703-2856-04 Pkg 25 Vial |
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REASON:
Teva Pharmaceuticals USA is voluntarily recalling the above lots of Propofol Injectable Emulsion, 10mg/ml. This recall is carried out to the USER level due to out of specification endotoxin results. Product was first shipped March 16, 2009.
Additional lots and items are due to the potential for elevated endotoxin results. This product was first shipped
February 2, 2009.
If you have questions or need additional information regarding this recall, please call Teva @1-866-262-1243.
ACTION:
- Please examine your inventory immediately for the specified lots of Propofol Injectable Emulsion, 10mg/ml.
- Immediately discontinue use and distribution of the product lots being recalled.
- Promptly complete the attached recall stock response and reply via fax to 215-799-5440 or mail, even if you have NO product to return.
Teva Pharmaceuticals USA, Inc.
1090 Horsham Road
PO Box 1090
North Wales, PA 19454
This recall is being conducted with the knowledge of the FDA.
Contact:
Media:Teva Pharmaceuticals 1-866-262-1243
