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%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pum…

Recall number

D-0033-2018

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%, 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