notyard
08-22-2009, 01:14 PM
FDA class III recall:
PRODUCT
Colchicine Injection, USP FOR IV USE1 mg/0.5 mg/mL Rx ONLY, NDC 55390-605-02 2 mL vial, Recall # D-1890-2009
CODE
Lot # 957876, Exp. Date 08/09
RECALLING FIRM/MANUFACTURER
Bedford Laboratories, Bedford, OH, by letters on August 3, 2009. Firm initiated recall is ongoing.
REASON
Failed PH Specification @ 24 months.
VOLUME OF PRODUCT IN COMMERCE
31,870 vials = 3,187 boxes/10/1mg/2mL vials
DISTRIBUTION
Nationwide and Israel
PRODUCT
Colchicine Injection, USP FOR IV USE1 mg/0.5 mg/mL Rx ONLY, NDC 55390-605-02 2 mL vial, Recall # D-1890-2009
CODE
Lot # 957876, Exp. Date 08/09
RECALLING FIRM/MANUFACTURER
Bedford Laboratories, Bedford, OH, by letters on August 3, 2009. Firm initiated recall is ongoing.
REASON
Failed PH Specification @ 24 months.
VOLUME OF PRODUCT IN COMMERCE
31,870 vials = 3,187 boxes/10/1mg/2mL vials
DISTRIBUTION
Nationwide and Israel