CLASS II Drug recall · Reported 15 Jun 2016 · FDA Enforcement Report
Norditropin FlexPro Somatropin (rDNA origin) injection recalled
Novo Nordisk is recalling Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/ Prefilled Pen, distributed nationwide in the US. The recall was initiated on 27 Apr 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0956-2016
- FDA event ID
- 74044
- Recalling firm
- Novo Nordisk, Princeton, NJ
- Brand
- Norditropin
- Manufacturer
- Novo Nordisk
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Apr 2016
- FDA classified
- 6 Jun 2016
- Reported
- 15 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Apr 2016 | Recall initiated by company | |
| 6 Jun 2016 | Classified by FDA | +40 days |
| 15 Jun 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21
Where it was distributed
Nationwide
Questions about this recall
Why was it 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 lots are affected?
Lot Number FC70222
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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