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
Product description
Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21
Lot numbers, UPCs & expiration codes
Lot Number FC70222
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0956-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 27, 2016
- FDA report date
- Jun 15, 2016
- Quantity
- 723 pens
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novo Nordisk Inc
Original FDA data
Every field from FDA enforcement report D-0956-2016, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 74044
- Address
- 1100 Campus Rd
- Code information
- Lot Number FC70222
- Postal code
- 08540-6650
- Report date
- Jun 15, 2016
- Product type
- Drugs
- Recall number
- D-0956-2016
- Classification
- Class II
- Recalling firm
- Novo Nordisk Inc
- Product quantity
- 723 pens
- Termination date
- May 2, 2017
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 27, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 6, 2016