Recalls / Class II

Class IID-0363-2024

Product

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

Affected lot / 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.

Why it was recalled

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

Recalling firm

Firm

Denver Solutions, LLC DBA Leiters Health

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

13796 Compark Blvd, Englewood, Colorado 80112-7145

Distribution

Quantity

40,890 vials

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2024-02-20

FDA classified

2024-02-29

Posted by FDA

2024-03-06

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0363-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.