January 2017 FDA Recall Duopa by Abbvie Inc.
D-0495-2017 - Failed Stability Specifications

This Class II drug recall was voluntarily initiated by Abbvie Inc. on January 13, 2017 for the product Duopa. The FDA reported the reason for recall as failed stability specifications. The product was distributed in TN and IL and the recall is currently terminated.

Recall Number: D-0495-2017

Reason for Recall
Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life
Initiated
01-13-2017
Reported
03-08-2017
Quantity
4021 cartons, 7 100-mL cassettes each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76199
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TN and IL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-15-2019
Product Description About Product Description
Full technical description of the product.
Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Only, AbbVie Inc., North Chicago, IL 60064 --- NDC 0074-3012-07

Batch or Lot Expiration Information

Lot# Lots: 1055692, Expiration Date (Frozen) 06/01/2018 1057881, Expiration Date (Frozen) 06/02/2018 1060138, Expiration Date (Frozen) 06/13/2018 1060140, Expiration Date (Frozen) 06/15/2018 1061258, Expiration Date (Frozen) 06/17/2018 1061262, Expiration Date (Frozen) 06/30/2018 1063033, Expiration Date (Frozen) 07/14/2018

Affected Packages Involved in this Recall

0074-3012-07 Duopa