The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0130-2019·Announced 2018-10-31

RXQ Compounding Recalls Subpotent Lidocaine and Epinephrine Injection Vials

RXQ Compounding LLC is recalling 395 vials of Lidocaine 1% + Epinephrine 1:100,000 injection solution because testing revealed the product was subpotent.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a subpotent drug where no illnesses or injuries have been reported, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

RXQ Compounding LLC is voluntarily recalling 395 vials of Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial. The product is prescription-only and was distributed nationwide in the United States. The specific lot affected is Lot# 04042018:58, with an expiration date of 10/17/18.

The recall was initiated after the firm discovered during testing of the retention sample that the product was subpotent. This means the medication did not contain the full amount of the active ingredients required by the label. No illnesses or injuries have been reported in connection with this recall.

Healthcare providers and patients who have this specific product should stop using it and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450
Manufacturer
RXQ Compounding LLC
Category
Drug — Injection
Hazard
Affected units
395

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 (2)

  • Lot# 04042018:58
  • Exp 10/17/18

Distribution

Distributed nationwide across the United States.

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