notyard
04-15-2009, 09:08 AM
FDA class II recall:
PRODUCT
ERBITUX (cetuximab), For Intravenous Use, 100 mg (2 mg/mL), single use 50 mL vial, Rx only, NDC 66733-948-23, Recall # D-211-2009
CODE
Lot numbers: 06Q00715, Exp. Jan 2010; 07Q00311A, Exp. Aug 2010, 07Q00311B, Exp. Aug 2010; 07T00312; Exp. Aug 2010; 07T00359A, Exp. Sep 2010; 07T00359C, Exp. Oct 2010; 07T00466A, Exp Nov 2010; 07T00663, Exp Dec 2010; 07T00664, Exp Dec 2010; 07T00677B, Exp. Dec. 2010; 07T00678, Exp Dec 2010; 07T00680, Exp. Dec 2010; 07T00681, Exp Dec 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: ImClone Systems Inc., Branchburg, NJ, by letters on March 5, 2009.
Manufacturer: Hollister Stier Laboratories LLC, Spokane, WA. Firm initiated recall is ongoing.
REASON
Cracks in vial: A product complaint identified leaking from underneath the cap of ERBITUX (cetuximab) 100 mg/50 mL vial, was found to be from undetected split finish cracks in the vial, possibly affecting the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
224,888 vials
DISTRIBUTION
Nationwide and Canada
PRODUCT
ERBITUX (cetuximab), For Intravenous Use, 100 mg (2 mg/mL), single use 50 mL vial, Rx only, NDC 66733-948-23, Recall # D-211-2009
CODE
Lot numbers: 06Q00715, Exp. Jan 2010; 07Q00311A, Exp. Aug 2010, 07Q00311B, Exp. Aug 2010; 07T00312; Exp. Aug 2010; 07T00359A, Exp. Sep 2010; 07T00359C, Exp. Oct 2010; 07T00466A, Exp Nov 2010; 07T00663, Exp Dec 2010; 07T00664, Exp Dec 2010; 07T00677B, Exp. Dec. 2010; 07T00678, Exp Dec 2010; 07T00680, Exp. Dec 2010; 07T00681, Exp Dec 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: ImClone Systems Inc., Branchburg, NJ, by letters on March 5, 2009.
Manufacturer: Hollister Stier Laboratories LLC, Spokane, WA. Firm initiated recall is ongoing.
REASON
Cracks in vial: A product complaint identified leaking from underneath the cap of ERBITUX (cetuximab) 100 mg/50 mL vial, was found to be from undetected split finish cracks in the vial, possibly affecting the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
224,888 vials
DISTRIBUTION
Nationwide and Canada