January 5, 2000Nordisk Pharmaceuticals
Recalls Certain Lots of NovolinÆ 70/30 PenFillÆ Insulin Product
Princeton, NJ (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Novo Nordisk Pharmaceuticals, Inc., has recalled
certain lots of its insulin - NovolinÆ 70/30 PenFillÆ because of Mislabeling - label
lacks listing of phenol 0.068% as ingredient/preservative.
This onging Class III recall was initiated
by the manufacturer by letter dated September 7, 1999. This is the first public
notice issued by the FDA.
Product described as:
NovolinÆ 70/30 PenFillÆ (70% NPH, Human Insulin Isophane suspension 30%
Regular, Human Insulin Injection-recombinant DNA origin), 1.5 mL cartridges, 100 units/mL
(U-100) in cartons of 5, Rx, intended usage is for individuals diagnosed with diabetes
requiring injections of insulin as prescribed by their physician. NDC #0169-1837-17.
CODE Lot Numbers: 9G14006 EXP 7/01 and 9J14015 EXP 9/01.
Approximately 11,816 cartons (5
cartridges/carton) were distributed nationwide.
FDA recall #D-185-0
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
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