FDA-Drug2025-04-30Class II
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
Denver Solutions, LLC DBA Leiters Health
Hazard
Lack of Assurance of Sterility: Leaking/damaged syringes.
Sold states
Nationwide in the U.S.A
Affected count
16,655 syringes
Manufactured in
13796 Compark Blvd, N/A, Englewood, CO, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0374-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief