Drug Enforcement D-0363-2024

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
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42
Product quantity
40,890 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-0363-2024
Event ID
94071
Recall initiation date
February 20, 2024
Center classification date
February 29, 2024
Code info
Lot #:2331104, Exp:9-Mar-24; 2331137, Exp: 3-Mar-24; 2331196, Exp: 11-Mar-24; 2331264, Exp: 6-Apr-24; 2331282, Exp: 18-Apr-24; 2331464, Exp: 8-May-24; 2331481, Exp: 16-May-24; 2331500, Exp: 20-May-24.
More code info
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