D-0362-2024 Class II Ongoing
FDA drug recall D-0362-2024 was initiated by Denver Solutions, LLC DBA Leiters Health on February 20, 2024 and is designated Class II. Reason for recall: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. The recall status is ongoing. Affected quantity: 10,020 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- March 6, 2024
- Initiation Date
- February 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,020 vials
Product Description
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
Reason for Recall
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #:2331123, Exp:28-Feb-24; 2331298, Exp: 24-Mar-24.