Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS recall
FDA recall D-0288-2024 · initiated Jan 19, 2024
OMEZA LLC recalled Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS in Jan 2024 — an FDA Class II recall (D-0288-2024) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4390 vials
Details
- Product
- Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
- Recalling company
- OMEZA LLC
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide
- Initiated
- Jan 19, 2024
- FDA report date
- Feb 14, 2024
Frequently asked
- Was Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS recalled?
- OMEZA LLC recalled Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS in Jan 2024 — an FDA Class II recall (D-0288-2024) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS recalled?
- Per the FDA enforcement record, the reason for recall D-0288-2024 was: CGMP Deviations
- Is a recalled Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS are affected?
- Distributed: US Nationwide. The recall covers these lots — Lots: 28622 2-1, Exp. 04/24/2024 286222-3, Exp. 1/25/2024 or 04/25/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0288-2024.