RXQ Compounding Recalls Lidocaine HCL 2% Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Lidocaine HCL 2% Injection Solution because the product lacks assurance of sterility. The recall covers all lots within their expiry dates.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies the hazard as 'Lack of Assurance of Sterility' for an injectable medication. Per the rubric, an FDA Class II recall involving a significant injury risk (injection of non-sterile product) without explicit reported hospitalizations or deaths maps to a score of 4 (Severe), as it represents a significant injury risk rather than a theoretical or minor issue.
Plain-English summary
RXQ Compounding LLC is voluntarily recalling Lidocaine HCL 2% Injection Solution (NPV), 20ml per vial, NDC 70731-0172-20. The recall was initiated because the product lacks assurance of sterility. The affected product is distributed nationwide in the United States.
The recall includes all lots of the product that are within their expiry dates. The source text does not specify the exact number of units recalled or the specific distribution dates.
Healthcare providers and patients should stop using the recalled product and contact their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- LIDOCAINE HCL 2% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0172-20
- Manufacturer
- RXQ Compounding LLC
- Category
- Drug — Injectable
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 (1)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by RXQ Compounding 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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