FDA Drug recall D-0956-2016
Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7…
- FDA Drug
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7… by Novo Nordisk, citing defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0956-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-27 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Novo Nordisk |
| Distribution | US |
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
Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
Identifiers
| ndc | 0169-7704-21 |
|---|---|
| ndc | 0169-7704-92 |
| ndc | 0169-7705-21 |
| ndc | 0169-7705-92 |
| ndc | 0169-7708-21 |
| ndc | 0169-7708-92 |
| ndc | 0169-7703-11 |
| ndc | 0169-7703-91 |
| ndc | 0169-7703-21 |
| ndc | 0169-7703-92 |
| code_info | Lot Number FC70222 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Novo Nordisk
- Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark,…
FDA Drug · Class II · 2026-01-07 · Novo Nordisk - Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, P…
FDA Drug · Class II · 2026-01-07 · Novo Nordisk - Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample
FDA Drug · Class I · 2021-04-21 · Novo Nordisk - NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample
FDA Drug · Class I · 2021-04-21 · Novo Nordisk - Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Ma…
FDA Drug · Class I · 2021-04-21 · Novo Nordisk
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0956-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.