Home / Recalls / AbbVie Inc. / D-0033-2018

D-0033-2018 Class III Terminated

Recalled by AbbVie Inc. — North Chicago, IL

Recall Details

Product Type
Drugs
Report Date
November 1, 2017
Initiation Date
September 8, 2017
Termination Date
April 23, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
520 pumps

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.

Distribution Pattern

AZ

Code Information

Lot: 91122, EXP. 01/2020

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  • D-0034-2018 Class III — AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packe (September 8, 2017)
  • Z-2178-2017 Class II — AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. (April 27, 2017)
  • Z-2177-2017 Class II — AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. (April 27, 2017)
  • Z-2176-2017 Class II — AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. (April 27, 2017)
  • D-0495-2017 Class II — Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL (January 13, 2017)
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