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January 5, 2000

Nordisk 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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Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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