RXQ Compounding Recalls Ketamine Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Ketamine 10 mg/mL Injection Solution due to a lack of assurance of sterility. The product was 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 FDA classified this recall as Class II. Per the rubric, an FDA Class II recall involving a significant risk of harm (lack of sterility in an injectable drug) corresponds to a severity score of 4 (Severe), as it implies a risk of adverse health consequences that may require medical intervention.
Plain-English summary
RXQ Compounding LLC is recalling Ketamine 10 mg/mL Injection Solution, a Schedule III controlled substance, due to a lack of assurance of sterility. The recall includes 2 mL and 5 mL syringes with NDCs 70731-0132-02 and 70731-0132-05, respectively. The product was distributed nationwide in the United States.
The FDA has classified 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 specific hazard identified is the potential for the product to be non-sterile, which poses a risk of infection if administered to patients.
Healthcare providers and patients who have received or used this product should contact their healthcare provider for guidance. The source text does not specify a particular lot number or expiration date, noting only that all lots within expiry are affected. Consumers should not use the recalled product and should follow instructions from their medical provider regarding alternative treatments or monitoring.
The recalled product
- Product
- KETAMINE 10 MG/ML INJ SOL SYR (C-III), [a) 2 ML NDC: 70731-0132-02; b) 5 ML NDC: 70731-0132-05] per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701.
- 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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