RXQ Compounding Recalls Lidocaine Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Lidocaine HCL 1% Injection Solution because the product lacks assurance of sterility. The recall covers all lots within expiry 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 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable medication, which poses a risk of serious adverse health consequences such as infection or sepsis, meeting the criteria for a Severe rating.
Plain-English summary
RXQ Compounding LLC is voluntarily recalling Lidocaine HCL 1% Injection Solution (NPV), 20ml per vial, under NDC 70731-0174-20. The recall is being conducted because the product lacks assurance of sterility. The affected product was distributed nationwide in the United States.
The recall includes all lots of the product that are within their expiration dates. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients should stop using the recalled product and return it to the distributor or contact RXQ Compounding LLC for further instructions. Consumers should consult their healthcare provider if they have questions regarding the use of this medication.
The recalled product
- Product
- LIDOCAINE HCL 1% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0174-20
- Manufacturer
- RXQ Compounding LLC
- Category
- Drug — Injectable Medication
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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