← FDA ENFORCEMENT
D-0289-2024Class 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
1210 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
CGMP Deviations
Product description
Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
Code / lot info
Lot: 19123 4-1, Exp. 05/11/2024
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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 →