Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Franci...

FDA Recall #D-087-2013 — Class II — September 20, 2012

Recall #D-087-2013 Date: September 20, 2012 Classification: Class II Status: Terminated

Product Description

Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01

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

10,306 syringes

Distribution

Nationwide

Code Information

Lot# 936674 Exp. 09/30/13

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated