The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1670-2019·Announced 2019-08-14

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.

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 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
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.

See all 86 products in this recall →

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