April 2016 FDA Recall Norditropin by Novo Nordisk Inc
D-0956-2016 - Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
This Class II drug recall was voluntarily initiated by Novo Nordisk Inc on April 27, 2016 for the product Norditropin. The FDA reported the reason for recall as defective delivery system; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0956-2016
Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
04-27-2016
06-15-2016
723 pens
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Novo Nordisk Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
05-02-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
