Duopa Suspension
FDA Recall NDC 0074-3012
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Duopa (NDC 0074-3012). A significant event, classified as Class II, was initiated on Jan 13, 2017 by Abbvie Inc.. The reported reason for this action was: "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"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
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
Jan 13, 2017
Mar 08, 2017
4021 cartons, 7 100-mL cassettes each
Recall Profile & Regulatory Data
Event ID
76199
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
AbbVie Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
TN and IL
Termination Date
Mar 15, 2019
Product Description
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
0074-3012-07Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
