Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compa
Summary
The FDA issued a Class II for Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- by Denver Solutions, LLC DBA Leiters Health. Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination..
Details
Source
Drug Recall
External ID
D-0363-2024
Action Date
2024-03-06
Status
Ongoing
Category
drug
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
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.
Quantity Affected: 40,890 vials
Reason for Recall
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-20
Company
Englewood, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 63 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Denver Solutions, LLC DBA Leiters Health has 22 FDA actions in our database, including 22 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Denver Solutions, LLC DBA Leiters Health) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Denver Solutions, LLC DBA Leiters Health have FDA actions?
Denver Solutions, LLC DBA Leiters Health has 22 FDA actions in our database, including 22 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0363-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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