← FDA ENFORCEMENT
D-0288-2024Class II

OMEZA LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
OMEZA LLC
Product type
Drug
Status
Terminated
Report date
2024-02-14
Distribution
US Nationwide
Firm state
FL
Product quantity
4390 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations

Product description

Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS

Code / lot info

Lots: 28622 2-1, Exp. 04/24/2024 286222-3, Exp. 1/25/2024 or 04/25/2024

Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →