Summary
The FDA issued a Class II for Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials by OMEZA LLC. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0289-2024
Action Date
2024-02-14
Status
Terminated
Category
drug
Product Description
Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
Lot/Code Info: Lot: 19123 4-1, Exp. 05/11/2024
Quantity Affected: 1210 vials
Reason for Recall
CGMP Deviations
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-19
Company
Sarasota, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
OMEZA LLC has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (OMEZA LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does OMEZA LLC have FDA actions?
OMEZA LLC has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0289-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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