Drug Enforcement D-0362-2024

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Status

Ongoing

Classification

Class II

Report Date

March 6, 2024

Termination Date

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Product Information

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
Product quantity
10,020 vials
Reason for recall
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Denver Solutions, LLC DBA Leiters Health
Address
13796 Compark Blvd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0362-2024
Event ID
94071
Recall initiation date
February 20, 2024
Center classification date
February 29, 2024
Code info
Lot #:2331123, Exp:28-Feb-24; 2331298, Exp: 24-Mar-24.
More code info
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