The Recall Desk
HighFDA (Drugs)·D-0846-2023·Announced 2023-06-07

Akorn Recalls All Lots of Sodium DIURIL Injectable Due to CGMP Deviations

Akorn Operating Company recalls all lots of Sodium DIURIL (chlorothiazide sodium) 0.5g/vial due to Current Good Manufacturing Practice deviations. The manufacturer was unable to complete required stability studies after the firm ceased operations.

What this means for you

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: FDA Class II recall involving a prescription injectable drug where stability testing could not be completed. Although no illnesses or injuries have been reported, incomplete stability data for a pharmaceutical product constitutes a potential risk of harm, as the drug's safety and effectiveness over time cannot be verified. This meets the rubric criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Akorn, Inc., has recalled all lots of Sodium DIURIL (chlorothiazide sodium) 0.5g/vial, a prescription injectable diuretic medication supplied as single-dose vials. The recall affects all lots distributed nationwide in the United States and Puerto Rico.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer was unable to complete required stability studies after the firm went out of business. Stability studies are a regulatory requirement to demonstrate that a pharmaceutical product remains safe and effective throughout its shelf life.

Healthcare providers and patients currently using this medication should discontinue use immediately and consult their healthcare provider or pharmacist regarding alternative treatment options. Any unused product should be returned to the dispensing pharmacy.

The recalled product

Product
Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Injectable / Diuretic
Hazard
  • cgmp-violation
  • incomplete-stability-testing

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.

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