FDA recall D-0956-2016

Novo Nordisk Inc · Class II · drug

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2016-04-27
Report date
2016-06-15
Termination date
2017-05-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

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