RXQ Compounding Recalls Dextrose 50% Injection Syringes Due to Sterility Concerns
RXQ Compounding LLC is recalling Dextrose 50% Injection Solution syringes 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the defect involves a critical quality attribute like sterility for an injectable product.
Plain-English summary
RXQ Compounding LLC is recalling Dextrose 50% Injection Solution (PF) Syringes, 50 ML per syringe, NDC 70731-0969-89. 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 within their expiration dates. The source text does not specify the number of units recalled or the specific dates of distribution.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm 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
- DEXTROSE 50% INJECTION SOLUTION (PF) SYRINGE, 50 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0969-89
- Manufacturer
- RXQ Compounding LLC
- Category
- Drug — Injectable Solution
- Hazard
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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