Lidocaine HCL 1% (10mg/mL) recall — Class II (D-0363-2024) · pharmaranks
Class IIOngoing
Lidocaine HCL 1% (10mg/mL) recall
FDA recall D-0363-2024 · initiated Feb 20, 2024
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Details
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
Recalling company
Denver Solutions, LLC DBA Leiters Health
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide in the USA
Initiated
Feb 20, 2024
FDA report date
Mar 6, 2024
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.