Drug 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
D-0495-2017
Product summary
- Firm
- AbbVie Inc.
- Event
- Event 76199
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4021 cartons, 7 100-mL cassettes each
- Official record key
drug-enforcement:D-0495-2017
Official wording
Reason: 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
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
Distribution pattern: TN and IL
Derived failure modes
-
Potency or specification failure
out of specification