Skip to content
Recall Observatory FDA recall evidence

Drug 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

D-0495-2017

January 13, 2017

Class II

Product summary

Firm
AbbVie Inc.
Event
Event 76199
Status
Terminated
Classification
Class II
Quantity
4021 cartons, 7 100-mL cassettes each
Official record key
drug-enforcement:D-0495-2017

Official wording

Reason: 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

Code information: 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

Distribution pattern: TN and IL

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification