Product Safety Recalls

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Recall D-0374-2025

Description: 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

Recall D-0374-2025 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0374-2025
Event ID96607
DistributionNationwide in the U.S.A
Quantity16,655 syringes
Recall ReasonLack of Assurance of Sterility: Leaking/damaged syringes.
Drug ClassificationClass II
Drug Code Info20250430
Recall Initiation Date20250331
Report Date20250430
Classification Date20250418
Address13796 Compark BlvdN/A
Englewood, CO 80112-7145
United States
Recalling FirmDenver Solutions, LLC DBA Leiters Health
Initial Notification Letter
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