The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0800-2023·Announced 2023-06-07

Diuril Injectable Drug Recalled Due to Manufacturing Quality Deviations

Akorn, Inc. is recalling all lots of Diuril (chlorothiazide sodium) Injection, 500mg/vial, distributed nationwide, due to manufacturing deviations. The manufacturer went out of business and was unable to complete required stability studies.

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: This is an FDA Class II recall for an injectable drug where the manufacturer was unable to complete required stability studies due to business closure. No illnesses or injuries have been reported. The hazard—unverified product stability and quality—is theoretical, making a High severity appropriate.

Plain-English summary

Diuril (chlorothiazide sodium) Injection, 500mg/vial, is being recalled by Akorn, Inc. The recall affects all lots of the product distributed nationwide in the United States and Puerto Rico.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer went out of business and could not complete the stability studies required to verify the product's safety and effectiveness throughout its shelf life. Without these studies, the product cannot be confirmed to meet FDA standards for quality and safety.

Patients and healthcare providers who have received or used this medication should consult with their healthcare provider about next steps. Patients should not use any remaining doses of this product. Unused product should be returned to the dispensing pharmacy or appropriate disposal facility.

The recalled product

Product
Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. 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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