Norditropin FlexPro Somatropin — Class II drug recall D-0956-2016
Terminated recall by Novo Nordisk Inc, reported 2016-06-15, distributed nationwide. Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the s
| Recall number | D-0956-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novo Nordisk Inc, Princeton, NJ, United States |
| Recall initiated | 2016-04-27 |
| Classified | 2016-06-06 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2017-05-02 |
| Distributed | Nationwide (US) |
| Quantity | 723 pens |
| NDC | 00169-7703, 00169-7703-11, 00169-7703-21, 00169-7703-91, 00169-7703-92, 00169-7704, 00169-7704-21, 00169-7704-92, 00169-7705, 00169-7705-21, 00169-7705-92, 00169-7708, 00169-7708-21, 00169-7708-92 |
| Lot numbers | FC70222 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0956-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.