The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1638-2019·Announced 2019-08-14

RXQ Compounding Recalls Buffered Lidocaine Injection Due to Sterility Concerns

RXQ Compounding LLC is recalling Buffered Lidocaine 1%+Epi 1:100,000 Injection Solution because the product lacks 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe; while no specific injuries are reported in the text, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of adverse health consequences, aligning with the Severe criteria for high-risk pathogens or significant injury potential in the absence of Class I classification.

Plain-English summary

RXQ Compounding LLC is recalling specific lots of Buffered Lidocaine 1%+Epi 1:100,000 Injection Solution. The recall was initiated because the product lacks assurance of sterility. The affected product is identified by NDC 70731-0137-03 (3mL) and 70731-0137-30 (30mL) and is distributed nationwide in the United States.

The source text does not specify the number of units recalled, specific lot numbers, or the exact dates of distribution. The recall covers all lots within the expiry date for the identified NDCs.

Healthcare providers and patients should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies 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.

The recalled product

Product
BUFFERED LIDOCAINE 1%+EPI 1:100,000 INJ SOL, [3ML NDC: 70731-0137-03 and 30ML NDC: 70731-0137-30] per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0137-03
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 →

Related recalls

Same manufacturer · RXQ Compounding LLC

See all →

Same hazard · sterility

See all →

Similar recalls