Moxifloxacin 5mg/ml recall
FDA recall D-0362-2024 · initiated Feb 20, 2024
Denver Solutions, LLC DBA Leiters Health recalled Moxifloxacin 5mg/ml in Feb 2024 — an FDA Class II recall (D-0362-2024) because Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 10,020 vials
Details
- Product
- Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
- Recalling company
- Denver Solutions, LLC DBA Leiters Health
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Feb 20, 2024
- FDA report date
- Mar 6, 2024
Frequently asked
- Was Moxifloxacin 5mg/ml recalled?
- Denver Solutions, LLC DBA Leiters Health recalled Moxifloxacin 5mg/ml in Feb 2024 — an FDA Class II recall (D-0362-2024) because Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Moxifloxacin 5mg/ml recalled?
- Per the FDA enforcement record, the reason for recall D-0362-2024 was: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Is a recalled Moxifloxacin 5mg/ml dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Moxifloxacin 5mg/ml are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #:2331123, Exp:28-Feb-24; 2331298, Exp: 24-Mar-24.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0362-2024.