FDA Drug recall D-1537-2020
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL…
- FDA Drug
- Class I
- terminated
- Published 2020-09-02
On 2020-09-02 the FDA classified a Class I recall of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL… 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-1537-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-07-22 |
| Published | 2020-09-02 |
| 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 per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 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 #: 6121853, Exp 05/2021; 6122207, Exp 06/2021 |
|---|
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-1537-2020%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.