FDA recall D-0034-2018

Product

AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-30

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-0034-2018