Norditropin Injection, Solution
FDA Recall NDC 0169-7708
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Norditropin (NDC 0169-7708). A significant event, classified as Class II, was initiated on Apr 27, 2016 by Novo Nordisk. The reported reason for this action was: "Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
April 2016 Class II Recall: Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
Recall Number
Class II Terminated
Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
Apr 27, 2016
Jun 15, 2016
723 pens
Recall Profile & Regulatory Data
Event ID
74044
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Novo Nordisk Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 02, 2017
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
Batch or Lot Expiration Information
Lot# Lot Number FC70222
Affected Packages Involved in this Recall
0169-7704-21Product
0169-7704-92Product
0169-7705-21Product
0169-7705-92Product
0169-7708-21Product
0169-7708-92Product
0169-7703-11Product
0169-7703-91Product
0169-7703-21Product
0169-7703-92Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
