Multi-event September 2017 FDA Recall Drug by Abbvie Inc.

This Multi-event Class III drug recall was voluntarily initiated by Abbvie Inc. on September 8, 2017 for the product Drug. The FDA reported the reason for recall as temperature abuse. The product was distributed in AZ and the recall is currently terminated.

Reported Recall Events

D-0033-2018 TERMINATED D-0034-2018 TERMINATED

Recall Number: D-0033-2018

Reason for Recall
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Initiated
09-08-2017
Reported
11-01-2017
Quantity
520 pumps

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78143
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AbbVie Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AZ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-23-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lot: 91122, EXP. 01/2020

Recall Number: D-0034-2018

Reason for Recall
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Initiated
09-08-2017
Reported
11-01-2017
Quantity
48 cartons (30 foil packets per carton)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78143
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AbbVie Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AZ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-23-2018
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# Lot: D60010A, EXP. 01/2019