US Drug Recall Register
Class III · Low risk Terminated Initiated Sep 8, 2017 (9 years ago)

AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

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

Recalling firm
AbbVie Inc.
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0034-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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