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Recall Observatory FDA recall evidence

Drug product

Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01

D-088-2013

September 20, 2012

Class II

Product summary

Firm
Genentech Inc
Event
Event 63243
Status
Terminated
Classification
Class II
Quantity
12,791 syringes
Official record key
drug-enforcement:D-088-2013

Official wording

Reason: 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).

Code information: Lot # 936670 Exp. 09/30/13

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).