The Recall Desk
HighFDA (Drugs)·D-0802-2023·Announced 2023-06-07

Ephedrine Sulfate Injection Recalled Due to Incomplete Stability Studies

Akorn, Inc. is recalling all lots of Ephedrine Sulfate Injection due to manufacturing compliance deviations; the firm was unable to complete required stability studies.

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 classification indicates a serious manufacturing compliance issue. The inability to complete required stability studies prevents verification of product safety and efficacy, representing a risk-of-harm product. No illnesses or injuries have been reported, placing this in the High (3) category per the severity rubric.

Plain-English summary

Akorn, Inc. is recalling all lots of Ephedrine Sulfate Injection, USP (50 mg/mL in 1 mL single-dose ampules for intravenous use), distributed nationwide in the USA and Puerto Rico.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. The recalling firm was unable to continue and complete the required stability studies to verify that the product maintains its safety and efficacy. The firm went out of business and could no longer conduct these studies.

Patients and healthcare providers with this product should contact their pharmacist or physician for guidance on their specific situation.

The recalled product

Product
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Injection
Hazard
  • cgmp-deviation
  • stability-verification-incomplete

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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