The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1705-2019·Announced 2019-08-14

RXQ Compounding Recalls Lidocaine Syringes Due to Sterility Concerns

RXQ Compounding LLC is recalling Lidocaine 0.75%/Epinephrine 0.025% syringes because the FDA determined there is a lack of assurance of sterility.

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, 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 (Critical) but represent a significant risk.

Plain-English summary

RXQ Compounding LLC is voluntarily recalling Lidocaine 0.75%/Epinephrine 0.025%/BSS 0.56ML Syringes (1 mL per syringe) under FDA recall number D-1705-2019. The product is identified by NDC 70731-0919-01 and was distributed nationwide in the United States. The recall covers all lots within their expiration dates.

The reason for the recall is a lack of assurance of sterility. 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, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients who have received or used these syringes should stop using them and contact their healthcare provider or the recalling firm for further instructions. Consumers should not attempt to use these products if they are unsure of their sterility status.

The recalled product

Product
LIDOCAINE 0.75%/Epinephrine 0.025%/BSS 0.56ML SYR, 1 ML PER Syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0919-01
Manufacturer
RXQ Compounding LLC
Category
Drug — Injectable Anesthetic
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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