Drug Enforcement D-0289-2024

CGMP Deviations

Status

Terminated

Classification

Class II

Report Date

February 14, 2024

Termination Date

October 17, 2024

Product Information

Product description
Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
Product quantity
1210 vials
Reason for recall
CGMP Deviations
Recall initiation reason
Initial firm notification
E-Mail
Distribution pattern
US Nationwide

Location & Firm

Recalling firm
OMEZA LLC
Address
1610 Northgate Blvd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0289-2024
Event ID
93847
Recall initiation date
January 19, 2024
Center classification date
February 4, 2024
Code info
Lot: 19123 4-1, Exp. 05/11/2024
More code info