Multi-event January 2024 FDA Recall Drug by Omeza Llc

This Multi-event Class II drug recall was voluntarily initiated by Omeza Llc on January 19, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0289-2024 TERMINATED D-0288-2024 TERMINATED

Recall Number: D-0289-2024

Reason for Recall
CGMP Deviations
Initiated
01-19-2024
Reported
02-14-2024
Quantity
1210 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93847
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
OMEZA LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-17-2024
Product Description About Product Description
Full technical description of the product.
Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials

Batch or Lot Expiration Information

Lot# Lot: 19123 4-1, Exp. 05/11/2024

Recall Number: D-0288-2024

Reason for Recall
CGMP Deviations
Initiated
01-19-2024
Reported
02-14-2024
Quantity
4390 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93847
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
OMEZA LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-17-2024
Product Description About Product Description
Full technical description of the product.
Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS

Batch or Lot Expiration Information

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