Drug Enforcement D-087-2013

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).

Status

Terminated

Classification

Class II

Report Date

December 12, 2012

Termination Date

December 24, 2013

Product Information

Product description
Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01
Product quantity
10,306 syringes
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).
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Genentech Inc
Address
1 DNA Way, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-087-2013
Event ID
63243
Recall initiation date
September 20, 2012
Center classification date
December 4, 2012
Code info
Lot# 936674 Exp. 09/30/13
More code info
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