The Recall Desk
SevereFDA (Drugs)·D-1707-2019·Announced 2019-08-14

RXQ Compounding Recalls Sterile Water for Injection Due to Sterility Concerns

RXQ Compounding LLC is recalling Sterile Water for Injection USP vials because the product lacks assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a product intended for injection, which poses a significant risk of serious injury.

Plain-English summary

RXQ Compounding LLC is recalling Sterile Water for Injection USP in 10, 30, and 50 mL vial sizes. The recall was initiated because the product lacks assurance of sterility.

The affected products are distributed nationwide in the United States. The recall includes all lots within their expiration dates. The specific NDC numbers for the recalled vials are 70731-0188-10, 70731-0188-30, and 70731-0188-50.

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

The recalled product

Product
STERILE WATER FOR INJECTION USP, [10, 30, or 50 ML] per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 10 ML vial: 70731-0188-10; NDC 30 ML vial: 70731-0188-30; NDC 50 ML vial: 70731-0188-50

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 →