Recalls / Class II
Class IID-088-2013
Product
Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01
- Affected lot / code info
- Lot # 936670 Exp. 09/30/13
Why it was recalled
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
- Firm
- Genentech Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 DNA Way, N/A, South San Francisco, California 94080-4918
Distribution
- Quantity
- 12,791 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-09-20
- FDA classified
- 2012-12-04
- Posted by FDA
- 2012-12-12
- Terminated
- 2013-12-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-088-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.