FDA recall D-0033-2018

Product

AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-33

Reason for recall

Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

Distribution

AZ

Key facts

Status

Terminated

Initiation date

2017-09-08

Report date

2017-11-01

Termination date

2018-04-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0033-2018