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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63243

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 20, 2012
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Genentech Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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

D-087-2013
Recall number
D-087-2013
Initiated
September 20, 2012
Classification
Class II
Status
Terminated
Recalling firm
Genentech Inc
Quantity
10,306 syringes

App-derived interpretation

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).

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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).

Code information

Lot# 936674 Exp. 09/30/13

Distribution pattern

Nationwide

drug · product 2 of 2

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

D-088-2013
Recall number
D-088-2013
Initiated
September 20, 2012
Classification
Class II
Status
Terminated
Recalling firm
Genentech Inc
Quantity
12,791 syringes

App-derived interpretation

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).

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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).

Code information

Lot # 936670 Exp. 09/30/13

Distribution pattern

Nationwide