The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1651-2019·Announced 2019-08-14

RXQ Compounding Recalls EDETATE DISODIUM 30% INJECTABLE Due to Sterility Concerns

RXQ Compounding LLC is recalling EDETATE DISODIUM 30% INJECTABLE, 100 ML vials, 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, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

RXQ Compounding LLC is recalling EDETATE DISODIUM 30% INJECTABLE, 100 ML per vial (NDC: 70731-0931-11). The recall was initiated because the product lacks assurance of sterility.

The affected product was distributed nationwide in the United States. All lots within the expiry date are included in this recall.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.

The recalled product

Product
EDETATE DISODIUM 30% INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0931-11
Manufacturer
RXQ Compounding LLC
Category
Drug — 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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