Enforcement Report - Week of December 12, 2012
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Product Detail
| Product Description | Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01 |
|---|---|
| Recall Number | D-087-2013 |
| Classification | Class II |
| Code Info | Lot# 936674 Exp. 09/30/13 |
| Product Distributed Qty | 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). |
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 |
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