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
- Company
- Abbvie Inc.
- Recall Initiated
- January 13, 2017
- Posted
- March 8, 2017
- Recall Number
- D-0495-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4021 cartons, 7 100-mL cassettes each
- Firm Location
- North Chicago, IL, United States
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
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
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