PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 8, 2017 Initiated: January 13, 2017 #D-0495-2017

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

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

Details

Recalling Firm
AbbVie Inc.
Units Affected
4021 cartons, 7 100-mL cassettes each
Distribution
TN and IL
Location
North Chicago, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by AbbVie Inc.. Units affected: 4021 cartons, 7 100-mL cassettes each.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Drug on March 8, 2017. Severity: Moderate. Recall number: D-0495-2017.