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Class II: temporary or reversible health riskTerminated

Genentech Nutropin AQ NuSpin 20 Recall

Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South…

Genentech Inc · South San Francisco, CA

Risk level
Class II
Reported by FDA
Dec 12, 2012
Recall ID
D-087-2013
Check your lot numberHow we source this data

Summary

Genentech recalled Nutropin AQ NuSpin 20 starting Sep 20, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-087-2013 on Dec 12, 2012. 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). Status: Terminated.

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).

Product description

Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01

Lot numbers, UPCs & expiration codes

Lot# 936674 Exp. 09/30/13

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-087-2013
Classification
Class II
Status
Terminated
Recall initiated
Sep 20, 2012
FDA report date
Dec 12, 2012
Quantity
10,306 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Genentech Inc

Original FDA data

Every field from FDA enforcement report D-087-2013, exactly as published.

Show all FDA fields
City
South San Francisco
State
CA
Status
Terminated
Country
United States
Event ID
63243
Address
1 DNA Way
Code information
Lot# 936674 Exp. 09/30/13
Postal code
94080-4918
Report date
Dec 12, 2012
Product type
Drugs
Recall number
D-087-2013
Classification
Class II
Recalling firm
Genentech Inc
Product quantity
10,306 syringes
Termination date
Dec 24, 2013
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).
Voluntary / mandated
Voluntary: Firm initiated
Product description
Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01
Distribution pattern
Nationwide
Recall initiation date
Sep 20, 2012
Initial firm notification
Letter
Center classification date
Dec 4, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-087-2013, published Dec 12, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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