Duopa — Class II drug recall D-0495-2017
Terminated recall by AbbVie Inc., reported 2017-03-08, distributed in IL, TN. Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material
| Recall number | D-0495-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AbbVie Inc., North Chicago, IL, United States |
| Recall initiated | 2017-01-13 |
| Classified | 2017-02-27 |
| Reported by FDA | 2017-03-08 |
| Terminated | 2019-03-15 |
| Distributed | IL, TN |
| Reason classes | specification failure |
| NDC | 00074-3012, 00074-3012-07 |
| Lot numbers | 1055692 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0495-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.