CLASS II Drug recall · Reported 8 Mar 2017 · FDA Enforcement Report
Duopa (carbidopa and levodopa enteral suspension) recalled by AbbVie
AbbVie is recalling Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL cassette, 7, distributed in Illinois, Tennessee. The recall was initiated on 13 Jan 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0495-2017
- FDA event ID
- 76199
- Recalling firm
- AbbVie, North Chicago, IL
- Brand
- Duopa
- Manufacturer
- AbbVie Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jan 2017
- FDA classified
- 27 Feb 2017
- Reported
- 8 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
Timeline
| 13 Jan 2017 | Recall initiated by company | |
| 27 Feb 2017 | Classified by FDA | +45 days |
| 8 Mar 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
TN and IL
Questions about this recall
Why was it 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
Which lots are affected?
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
Where was it sold?
TN and IL
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Carbidopa recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg recalledCarbidopa, Levodopa And Entacapone | Rising Pharma Holding | Packaging Defects | Nationwide |
| Drug | CLASS II | Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, Unit Dose recalled | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Carbidopa And Levordopa Tablets, USP 25mg/100mg recalled | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Carbidopa and Levodopa Tablets, USP 25 mg/250mg recalled by Mayne Pharma | Mayne Pharma | Packaging Defects | Nationwide |
| Drug | CLASS II | Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg recalledCarbidopa And Levodopa | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |