AbbVie Inc. recalls Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx On…

Recall date

January 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0495-2017

FDA classification

Class II

Brand / firm

AbbVie Inc.

Sold / distributed

TN and IL

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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