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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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Product Detail

Product Description Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01
Recall Number D-088-2013
Classification Class II
Code Info Lot # 936670 Exp. 09/30/13
Product Distributed Qty 12,791 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).

Event Detail

Event Id 63243
Product Type Drugs
Status Ongoing
Recalling Firm Genentech Inc
City South San Francisco
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide