PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: November 1, 2017 Initiated: September 8, 2017 #D-0033-2018

Product Description

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.

Details

Recalling Firm
AbbVie Inc.
Units Affected
520 pumps
Distribution
AZ
Location
North Chicago, IL

Frequently Asked Questions

What product 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. Recalled by AbbVie Inc.. Units affected: 520 pumps.
Why was this product recalled?
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 1, 2017. Severity: Low. Recall number: D-0033-2018.