AndroGel 1 recalled over temperature-control failures

Recall date

September 8, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

AbbVie Inc. recalls AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: Ab…

Recall number

D-0034-2018

FDA classification

Class III

Brand / firm

AbbVie Inc.

Sold / distributed

AZ

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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