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
Reported: March 6, 2024 Initiated: February 20, 2024 #D-0363-2024
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
Reason for Recall
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Details
- Recalling Firm
- Denver Solutions, LLC DBA Leiters Health
- Units Affected
- 40,890 vials
- Distribution
- Nationwide in the USA
- Location
- Englewood, CO
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Denver Solutions, LLC DBA Leiters Health. Units affected: 40,890 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 6, 2024. Severity: Moderate. Recall number: D-0363-2024.
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