FDA-Drug2017-03-08Class II

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

AbbVie Inc.
Hazard

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

Sold states
TN and IL
Affected count
4021 cartons, 7 100-mL cassettes each
Manufactured in
1 N Waukegan Rd, N/A, North Chicago, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0495-2017

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