D-0956-2016 Class II Terminated

Recalled by Novo Nordisk Inc — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
June 15, 2016
Initiation Date
April 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