FDA Drug recall D-0120-2021
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lak…
- FDA Drug
- Class I
- terminated
- Published 2020-12-16
On 2020-12-16 the FDA classified a Class I recall of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lak… by Fresenius Kabi Usa, citing cross Contamination with other products: trace amounts of lidocaine.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0120-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-11-17 |
| Published | 2020-12-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
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
Cross Contamination with other products: trace amounts of lidocaine
Identifiers
| code_info | Lot #: 6123925 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0120-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.