Class II
Ongoing
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
This recall is currently active, issued April 30, 2025. It was issued by Denver Solutions, Llc Dba Leiters Health.
- Recall Initiated
- March 31, 2025
- Posted
- April 30, 2025
- Recall Number
- D-0374-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 16,655 syringes
- Firm Location
- Englewood, CO, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility: Leaking/damaged syringes.
Distribution
Nationwide in the U.S.A
Lot / Code Info
Lot #:2530023, Exp.: 7/12/2025
More recalls by Denver Solutions, Llc Dba Leiters Health
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only,...
Mar 6, 2024 · Class II
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV us...
Feb 7, 2024 · Class I
VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding H...
Nov 1, 2023 · Class III
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026