RXQ Compounding Recalls Ondansetron Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Ondansetron 2 mg/mL 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. The hazard of 'Lack of Assurance of Sterility' in an injectable drug poses a significant risk of serious injury, such as infection or sepsis, which aligns with the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
RXQ Compounding LLC is voluntarily recalling Ondansetron 2 mg/mL Injection Solution (NPF), 20 mL per vial, NDC 70731-0157-20. The recall was initiated 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 source text does not specify the number of units recalled or the specific dates of distribution.
Healthcare providers and patients should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on alternative treatments or replacements. Consumers should not attempt to use the product if they are unsure of its status.
The recalled product
- Product
- ONDANSETRON 2 MG/ML INJECTION SOLUTION (NPF), 20ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0157-20
- Manufacturer
- RXQ Compounding LLC
- Category
- Drug — Injectable Solution
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.
See all 86 products in this recall →Related recalls
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