Moxifloxacin single-dose vials recalled for glass delamination nationwide
Denver Solutions is recalling 10,020 vials of Moxifloxacin 5mg/ml nationwide due to glass delamination in the vial packaging. Affected lots: 2331123 (exp. 2/28/24) and 2331298 (exp. 3/24/24).
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II drug recall with glass particulate matter and no reported illnesses. Per the severity rubric, 'risk-of-harm products where injury has not yet been reported' score 3 (High).
Plain-English summary
Denver Solutions, LLC (DBA Leiters Health) is recalling 10,020 vials of Moxifloxacin 5mg/ml due to glass delamination in the vial packaging. The delamination process introduces glass particulate matter into the product.
The affected lots are Lot 2331123 (expiration February 28, 2024) and Lot 2331298 (expiration March 24, 2024). The product is distributed nationwide. It is a prescription-only medication identified by NDC 71449-097-42.
Healthcare providers and patients who have this product should consult their prescriber or pharmacist. Do not use any vials from the affected lots.
The recalled product
- Product
- Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Category
- Drug
- Hazard
- glass-delamination
- particulate-matter
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #:2331123
- Exp:28-Feb-24
- 2331298
- Exp: 24-Mar-24.
Distribution
Distributed nationwide across the United States.
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