The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1689-2019·Announced 2019-08-14

RXQ Compounding Recalls Niacinamide Vials Due to Sterility Concerns

RXQ Compounding LLC is recalling Niacinamide 100mg/mL vials because the product lacks assurance of sterility. The recall covers all lots within expiry 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a lack of assurance of sterility, which poses a risk of harm (infection) but the source text does not report specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

RXQ Compounding LLC is voluntarily recalling Niacinamide 100mg/mL, 10mL vials (NDC: 70731-0938-10) due to a lack of assurance of sterility. The product is manufactured by RXQ Compounding LLC, located at 340 West State Street, Unit 9, Athens, OH 45701.

The recall includes all lots within their expiration dates. The distribution pattern for the affected product is nationwide in the United States.

Consumers and healthcare providers should stop using the recalled 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
NIACINAMIDE 100MG/ML, 10ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0938-10
Manufacturer
RXQ Compounding LLC
Category
Drug — Compounded Injectable
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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