Omeza Lidocaine Lavage pain relief oil recalled for manufacturing practice violations
OMEZA LLC has recalled Omeza Lidocaine Lavage pain relief oil (4,390 vials) due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily on January 19, 2024.
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: FDA Class II recall for manufacturing practice deviations represents a risk-of-harm situation affecting product quality and safety. Although no illnesses or injuries have been reported, the violation of current manufacturing practices meets the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
OMEZA LLC initiated a voluntary recall of Omeza Lidocaine Lavage pain relief oil on January 19, 2024, in response to Current Good Manufacturing Practice (CGMP) deviations. The recall covered 4,390 vials with lot numbers 28622 2-1 (expiration 04/24/2024) and 286222-3 (expiration 01/25/2024 or 04/25/2024).
The product was distributed nationwide. CGMP deviations indicate violations of manufacturing practices and controls that are essential for ensuring product safety and quality. No illnesses or injuries have been reported in connection with this product.
Consumers should discontinue use of affected lots and consult their healthcare provider if they have concerns about prior use of this product. This recall was formally terminated on October 17, 2024.
The recalled product
- Product
- Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
- Manufacturer
- OMEZA LLC
- Category
- Drug — Topical Drug
- 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 (3)
- Lots: 28622 2-1
- Exp. 04/24/2024 286222-3
- Exp. 1/25/2024 or 04/25/2024
Distribution
Distributed nationwide across the United States.
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