RXQ Compounding Recalls Dextrose 50% Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Dextrose 50% Injection Solution vials because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls with potential for serious injury (implied by sterility failure in an injectable) or hospitalization reports fall under Severe. While no specific injuries are reported, the agency classification and the nature of the defect (sterility in an injectable) align with the Severe criteria for significant risk.
Plain-English summary
RXQ Compounding LLC is recalling Dextrose 50% Injection Solution (PF) vials, 50 ML per vial, due to a lack of assurance of sterility. The affected product is identified by NDC 70731-0969-89. The recall includes all lots within their expiration dates.
The recall is classified as FDA Class II. The product was distributed nationwide in the United States. The source text does not specify the number of units recalled or report any specific illnesses or injuries associated with the product.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The FDA has not provided specific guidance on disposal or replacement in the provided text.
The recalled product
- Product
- DEXTROSE 50% INJECTION SOLUTION (PF) VIAL, 50 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0969-89
- 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.
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