CLASS II Drug recall · Reported 12 Dec 2012 · FDA Enforcement Report

Nutropin AQ NuSpin 20 (somatropin recalled by Genentech

Genentech is recalling Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ Genentech, South San, distributed nationwide in the US. The recall was initiated on 20 Sep 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot# 936674 Exp. 09/30/13
Quantity recalled10,306 syringes

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-087-2013
FDA event ID
63243
Recalling firm
Genentech, South San Francisco, CA
Classification
Class II
Status
Terminated
Recall initiated
20 Sep 2012
FDA classified
4 Dec 2012
Reported
12 Dec 2012
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

20 Sep 2012Recall initiated by company
4 Dec 2012Classified by FDA+75 days
12 Dec 2012Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

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

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Why was it 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).

Which lots are affected?

Lot# 936674 Exp. 09/30/13

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 63243
ReportedClassRecallCompanyReasonWhere
CLASS IINutropin AQ NuSpin 10 (somatropin recalled by GenentechGenentechOtherNationwide

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