SafetyAlerts
December 6, 2002
Novo Nordisk Has Recalled Novolin 70/30 InnoLet
The
Food and Drug Administration (FDA) has released the following
information.
PRODUCT
Novolin 70/30 InnoLet, 70% NPH, Human Insulin Isophane Suspension and
30% Regular, Human
Insulin Injection (rDNA origin), 100 units/mL, 3mL Prefilled Insulin
Syringes, Novo Nordisk.
Recall # D-062-3.
CODE
Lot # MS 60812 Exp. 6/2004
NDC# 0169-2317-21.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novo Nordisk Pharmaceuticals, Princeton, NJ, by fax on
August 16, 2002.
Manufacturer: Novo Nordisk A/S Bagsvaerd, Denmark. Firm initiated recall
is ongoing.
REASON
Defective container; delivery system may dispense less than the expected
amount of insulin
VOLUME OF PRODUCT IN COMMERCE
83,789 units.
DISTRIBUTION
Nationwide and Puerto Rico.
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