Drug recall D-0495-2017
Product
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
Lots and codes
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
Recall details
- Recalling firm
- AbbVie Inc., North Chicago, IL
- Quantity
- 4021 cartons, 7 100-mL cassettes each
- Distribution
- TN and IL
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 13, 2017
- Terminated
- March 15, 2019
Related products
- Duopa – drug information
- NDC 0074-3012 Duopa · Levodopa 20 mg/mL; Carbidopa Hydrate 4.63 mg/mL · AbbVie Inc.