The Recall Desk
HighFDA (Drugs)·D-0289-2024·Announced 2024-02-14

FDA Recalls Omeza Skin Protectant Gel Due to Manufacturing Deviations

OMEZA LLC is recalling Omeza Skin Protectant Gel due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 1,210 vials distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall, but there are no reports of illness or injury associated with the product. The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations, representing a potential quality control issue rather than documented harm. Per the rubric, when the hazard is theoretical with no reported illnesses or injuries, the score is at most 3.

Plain-English summary

OMEZA LLC is recalling Omeza Skin Protectant Gel, supplied in 10*2mL vials (Lot 19123 4-1, expiration 05/11/2024).

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The firm voluntarily initiated this recall on January 19, 2024, and it was terminated on October 17, 2024.

Approximately 1,210 vials were distributed nationwide in the United States. The affected lot number is 19123 4-1 with expiration date 05/11/2024.

Consumers who have this product should stop using it. Contact OMEZA LLC or consult a healthcare provider if you have questions or concerns about the recall.

The recalled product

Product
Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
Manufacturer
OMEZA LLC
Category
Drug — Topical Skin Protectant
Hazard
  • manufacturing-deviation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category