Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 casse...
FDA Drug Recall #D-0495-2017 — Class II — January 13, 2017
Recall Summary
| Recall Number | D-0495-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 13, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | AbbVie Inc. |
| Location | North Chicago, IL |
| Product Type | Drugs |
| Quantity | 4021 cartons, 7 100-mL cassettes each |
Product Description
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
Distribution Pattern
TN and IL
Lot / 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
Other Recalls from AbbVie Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0664-2024 | Class II | Refresh P.M., (Mineral Oil 42.5%, White Petrola... | Sep 16, 2024 |
| D-0665-2024 | Class II | Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% W... | Sep 16, 2024 |
| D-0088-2024 | Class III | Synthroid, Levothyroxine Sodium Tablets, USP 12... | Oct 17, 2023 |
| D-0412-2018 | Class III | Ultane (sevoflurane), 250 mL, Inhalation Anesth... | Jan 22, 2018 |
| D-0034-2018 | Class III | AndroGel (testosterone gel) 1.62%, 40.5mg in 2.... | Sep 8, 2017 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.