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.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1,210
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.
Part of a larger recall action
This product is one of 2 recalled by OMEZA LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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