Enforcement Report - Week of December 12, 2012
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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 |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01 | Lot# 936674 Exp. 09/30/13 | Class II | 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). | 10,306 syringes | D-087-2013 |
| Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01 | Lot # 936670 Exp. 09/30/13 | Class II | 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). | 12,791 syringes | D-088-2013 |
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