AbbVie Inc.: 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

Is my product affected?

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

• Brand DUOPA

Check against the official notice below — it lists the full affected range.

What happened

AbbVie Inc. is recalling Duopa (carbidopa and levodopa enteral suspension) 4.63 mg/20 mg per mL in 100 mL cassettes distributed in Tennessee and Illinois. The recall affects 4,021 cartons, each containing 7 cassettes, across seven specific lot numbers with frozen expiration dates ranging from June 1, 2018 to July 14, 2018. The product is being recalled because stability testing showed that the drug may settle within the cassettes as they near the end of their refrigerated shelf-life, causing the medication to fall out of specification.

The source does not specify what actions affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

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

Details from the source

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 Distribution: TN and IL Quantity: 4021 cartons, 7 100-mL cassettes each Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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