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Crohn's Disease Forum » Treatment » Humira/Adalimumab » Recalled Humira injection pens


03-15-2010, 09:22 AM   #1
D Bergy
Senior Member
 
Join Date: Apr 2007
Recalled Humira injection pens

I m not sure how most people use Humira, but in case you are using this product, I though it would not hurt to post it. This is an FDA recall.

http://www.fda.gov/Safety/Recalls/En.../ucm204085.htm


PRODUCT
Humira (adalimumab) Pen, for subcutaneous use only, 40 mg/0.8mL, 4 single-use prefilled pens (NDC 0074-4339-02) per Psoriasis Starter Package (NDC 0074-4339-07), UPC 3 00744 33907 8, Rx only. Recall # D-347-2010
CODE
Lot # 70266SP44, Exp SEP 2010; 74329SP41, Exp JAN 2011; 74329SP42, Exp JAN 2011; and 74329SP45, Exp JAN 2011
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL, by letters dated February 2, 2010. Firm initiated recall is ongoing.
REASON
Unit Dose Mispackaging: Some of the Humira Psoriasis Starter Packages may have been assembled in a configuration in which the positions of the pens within the Starter Package carton were inconsistent with the intended positions correlating to the recommended initial dosing regimen.
VOLUME OF PRODUCT IN COMMERCE
11,813 starter packages
DISTRIBUTION
Nationwide, Bermuda, Cayman Islands
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Crohn's Disease Forum » Treatment » Humira/Adalimumab » Recalled Humira injection pens
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