FDA Drug recall D-0374-2025
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112
- FDA Drug
- Class II
- ongoing
- Published 2025-04-30
On 2025-04-30 the FDA classified a Class II recall of Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112 by Denver Solutions, citing lack of Assurance of Sterility: Leaking/damaged syringes.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0374-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-31 |
| Published | 2025-04-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Denver Solutions |
| Distribution | US |
Product
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
Reason
Lack of Assurance of Sterility: Leaking/damaged syringes.
Identifiers
| code_info | Lot #:2530023, Exp.: 7/12/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0374-2025%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.