FDA recall D-087-2013

Genentech Inc · Class II · drug

Product

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

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).

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-09-20
Report date: 2012-12-12
Termination date: 2013-12-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: South San Francisco, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-087-2013