The Recall Desk

FDA (Drugs) recall action 63243

Genentech Inc recalled 2 products on 2012-12-12

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-12-12
Critical
0
Units
23,097

Why these products were 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).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2012-12-12

    Genentech Recalls Nutropin AQ NuSpin 20 Due to Defective Delivery System

    Genentech is recalling 10,306 syringes of Nutropin AQ NuSpin 20 because the dose knob may spin slowly, causing delayed injection delivery.

    Product
    Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2012-12-12

    Genentech Recalls Nutropin AQ NuSpin 10 Due to Defective Delivery System

    Genentech is recalling 12,791 syringes of Nutropin AQ NuSpin 10 because the dose knob may spin slowly, causing delayed injection delivery.

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