Drug Enforcement D-0361-2024

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

—

Product Information

Product description
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42
Product quantity
40,090 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-0361-2024
Event ID
94071
Recall initiation date
February 20, 2024
Center classification date
February 29, 2024
Code info
Lot #:2331147, Exp:6-Mar-24; 2331180, Exp: 21-Mar-24; 2331256, Exp: 2-Apr-24; 2331279, Exp: 3-Apr-24; 2331283, Exp: 7-Apr-24; 2331345, Exp: 20-Apr-24; 2331422, Exp: 27-Apr-24; 2331563, Exp: 29-May-24.
More code info
—