Recalls / Class II
Class IID-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
- Brand name
- Duopa
- Generic name
- Carbidopa And Levodopa
- Active ingredients
- Carbidopa Hydrate, Levodopa
- Route
- Enteral
- NDC
- 0074-3012
- FDA application
- NDA203952
- Affected 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
Why it was recalled
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
Recalling firm
- Firm
- AbbVie Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1 N Waukegan Rd, N/A, North Chicago, Illinois 60064-1802
Distribution
- Quantity
- 4021 cartons, 7 100-mL cassettes each
- Distribution pattern
- TN and IL
Timeline
- Recall initiated
- 2017-01-13
- FDA classified
- 2017-02-27
- Posted by FDA
- 2017-03-08
- Terminated
- 2019-03-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0495-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.