D-0374-2025 Class II Ongoing
FDA drug recall D-0374-2025 was initiated by Denver Solutions, LLC DBA Leiters Health on March 31, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Leaking/damaged syringes. The recall status is ongoing. Affected quantity: 16,655 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- April 30, 2025
- Initiation Date
- March 31, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,655 syringes
Product 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
Reason for Recall
Lack of Assurance of Sterility: Leaking/damaged syringes.
Distribution Pattern
Nationwide in the U.S.A
Code Information
Lot #:2530023, Exp.: 7/12/2025