RXQ Compounding Recalls Potassium Chloride Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Potassium Chloride 15% Injection Solution due to a lack of 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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.
Plain-English summary
RXQ Compounding LLC is voluntarily recalling Potassium Chloride 15% (2MEQ/ML) Injection Solution, 30 mL per vial (NDC: 70731-0954-30). The recall was initiated because the manufacturer could not ensure the sterility of the product. The affected product is 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, indicating a situation where 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 contact RXQ Compounding LLC for further instructions or a replacement. Consumers should not use the product if they have any concerns about its sterility or integrity.
The recalled product
- Product
- POTASSIUM CHLORIDE 15% (2MEQ/ML) INJ SOLN, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0954-30
- 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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