D-0495-2017 Class II Terminated
FDA drug recall D-0495-2017 was initiated by AbbVie Inc. on January 13, 2017 and is designated Class II. 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… The recall status is terminated (terminated March 15, 2019). Affected quantity: 4021 cartons, 7 100-mL cassettes each.
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