Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Franci...
FDA Recall #D-088-2013 — Class II — September 20, 2012
Product Description
Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01
Reason for Recall
Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
Recalling Firm
Genentech Inc — South San Francisco, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
12,791 syringes
Distribution
Nationwide
Code Information
Lot # 936670 Exp. 09/30/13
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated