Safety Alerts & Recalls

What does this mean?

At this time, there have been no patient reports of problems with these recalled lots of Enbrel SureClick Autoinjector, 50 mg/mL. However, since the recalled lots did not meet manufacturing standards and could possibly expose you a contaminated solution, you may wish to check your prescription to see if your supply is involved in the recall. If you use Enbrel, check to see if any of your supply is Enbrel (etanercept) SureClick Autoinjector, 50 mg/mL labeled with lot numbers listed in the recall. The lot number should be printed on the autoinjector or the outer packaging. If you think your Enbrel prescription is involved in the recall or if you do not know, please return your prescription to your pharmacist to examine and possibly exchange.

If you have any questions or concerns about this recall, please follow up with your doctor or pharmacist. If you think you are experiencing side effects from Enbrel (or etanercept), please contact your doctor as soon as possible.

Recall of Several Lots of Enbrel (etanercept) SureClick Autoinjector, 50 mg/mL

Amgen is recalling several lots of Enbrel (etanercept) SureClick Autoinjector, 50 mg/mL because there is concern that the syringe device is off-center and may result in broken or cracked syringes. The NDC product codes and lot numbers involved in the recall include: a) Enbrel (etanercept) SureClick Autoinjector, 50 mg/mL, NDC 58406-445-04: 4 single-use prefilled autoinjectors per carton

Lot numbers: 1005228, exp 3/2011; 1006109, exp 5/2011; 1010348, exp 6/2011; 1005945, exp 3/2011; 1007963, exp 5/2011; 1010349, exp 11/2011; 1005946, exp 3/2011; 1007964, exp 6/2011; 1010570, exp 9/2011; 1006035, exp 4/2011; 1009200, exp 5/2011; 1011162, exp 12/2011; 1006091, exp 2/2011; 1009201, exp 5/2011; 1011235, exp 1/2012; 1006092, exp 4/2011; 1009202, exp 6/2011; 1011236, exp 1/2012; 1006095, exp 4/2011; 1009203, exp 6/2011; 1011237, exp 2/2012; 1006100, exp 4/2011; 1009206, exp 10/2011; 1011875, exp 2/2012; 1006106, exp 5/2011; 1009726, exp 11/2011; 1012737, exp 2/2012; 1006107, exp 5/2011; 1010346, exp 4/2011; 1006108, exp 5/2011; 1010347, exp 5/2011

b) Enbrel (etanercept) SureClick Autoinjector, 50 mg/mL, NDC 58406-445-01: 1 single-use prefilled autoinjector

Lot numbers: 1006119, exp 4/2011; 1006771, exp 5/2011; 1006774, exp 6/2011; 1007225, exp 4/2011; 1007795, exp 4/2011; 1010351, exp 12/2011

Enbrel contains the active ingredient etanercept. Enbrel is a medicine given by subcutaneous injection to relieve the symptoms of certain autoimmune disorders including rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis (JIA), ankylosing spondylitis, and chronic plaque psoriasis.

For more information, please visit: more information here

Source: FDA
Publication Date: 2010-01-28
Last Updated: 2010-01-29

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