Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21
Reported: June 15, 2016 Initiated: April 27, 2016 #D-0956-2016
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
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
Details
- Recalling Firm
- Novo Nordisk Inc
- Units Affected
- 723 pens
- Distribution
- Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21. Recalled by Novo Nordisk Inc. Units affected: 723 pens.
Why was this product recalled? ▼
Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 15, 2016. Severity: Moderate. Recall number: D-0956-2016.
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