D-0495-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2017
- Initiation Date
- January 13, 2017
- Termination Date
- March 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4021 cartons, 7 100-mL cassettes each
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
Distribution Pattern
TN and IL
Code Information
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