Dexmedetomidine HCl in 0 — Class I drug recall D-0120-2021
Terminated recall by Fresenius Kabi USA, LLC, reported 2020-12-16, distributed nationwide. Cross Contamination with other products: trace amounts of lidocaine
| Recall number | D-0120-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2020-11-17 |
| Classified | 2020-12-08 |
| Reported by FDA | 2020-12-16 |
| Terminated | 2022-09-12 |
| Distributed | Nationwide (US) |
| Quantity | 13,525 bottles |
| NDC | 63323-0671-05 |
| Lot numbers | 6123925 |
Product
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05
Reason for recall
Cross Contamination with other products: trace amounts of lidocaine
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-0120-2021. 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.