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

FDA recall notice · announced June 15, 2016 · Novo Nordisk

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide
Lot/code information: Lot Number FC70222
Quantity: 723 pens
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.