FDA-Drug2016-06-15Class II

Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21

Novo Nordisk Inc
Hazard

Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step

Sold states
Nationwide
Affected count
723 pens
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0956-2016

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