D-0956-2016 Class II Terminated
FDA drug recall D-0956-2016 was initiated by Novo Nordisk Inc on Apr 27, 2016 and is designated Class II. 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 The recall status is terminated (terminated May 2, 2017). Affected quantity: 723 pens.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 15, 2016
- Initiation Date
- Apr 27, 2016
- Termination Date
- May 2, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 723 pens
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
Distribution Pattern
Nationwide
Code Information
Lot Number FC70222
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0956-2016
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026