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
FDA recall notice · announced November 1, 2017 · Abbvie
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The 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.
Notes
Distribution: AZ
Lot/code information: Lot: D60010A, EXP. 01/2019
Quantity: 48 cartons (30 foil packets per carton)
Status: Terminated
Products in this recall event:
- 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 (D-0033-2018)
- 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 (D-0034-2018)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.