FDAHealthMarch 31, 2025
Denver Solutions, LLC DBA Leiters Health — 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
⚠️ Lack of Assurance of Sterility: Leaking/damaged syringes.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 31, 2025
Nationwide in the U.S.A
What's affected?
- 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
- Lot code
- 2530023
Additional details
Lot #:2530023, Exp.: 7/12/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 16,655 syringes.
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