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
D-0956-2016
Product summary
- Firm
- Novo Nordisk Inc
- Event
- Event 74044
- Status
- Terminated
- Classification
- Class II
- Quantity
- 723 pens
- Official record key
drug-enforcement:D-0956-2016
Official wording
Reason: Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
Code information: Lot Number FC70222
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step