AbbVie Recalls Duopa Carbidopa and Levodopa Cassettes for Stability Issues
AbbVie is recalling Duopa (carbidopa and levodopa) cassettes because stability testing showed the drug may settle near the end of its shelf life.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the recall as FDA Class II. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when the defect involves a significant deviation from specifications that could impact drug efficacy or safety.
Plain-English summary
AbbVie Inc. is recalling specific lots of Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassettes. The recall involves 4,021 cartons, each containing seven 100-mL cassettes. The affected lots were distributed in Tennessee and Illinois.
The recall was initiated because confirmed out-of-specification results were obtained during refrigerated material stability testing. These results indicate that the drug may settle within the drug cassettes as they near the end of their refrigerated shelf life. The agency has classified this as a Class II recall.
Patients and healthcare providers should stop using the affected cassettes and contact their healthcare provider or pharmacist for instructions on how to obtain a replacement. The specific lot numbers and expiration dates are listed in the official recall notice.
The recalled product
- Product
- DUOPA (CARBIDOPA AND LEVODOPA)
- Brand
- DUOPA
- Manufacturer
- AbbVie Inc.
- Category
- Drug — Prescription Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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
UPCs (1)
- 0300743012071
Distribution
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