Recalls / Class II
Class IID-0956-2016
Product
Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21
- Brand name
- Norditropin
- Generic name
- Somatropin
- Active ingredient
- Somatropin
- Route
- Subcutaneous
- NDCs
- 0169-7703, 0169-7704, 0169-7705, 0169-7708
- FDA application
- BLA021148
- Affected lot / code info
- Lot Number FC70222
Why it was recalled
Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
Recalling firm
- Firm
- Novo Nordisk Inc
- Manufacturer
- Novo Nordisk
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1100 Campus Rd, N/A, Princeton, New Jersey 08540-6650
Distribution
- Quantity
- 723 pens
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-04-27
- FDA classified
- 2016-06-06
- Posted by FDA
- 2016-06-15
- Terminated
- 2017-05-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0956-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.