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.
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: 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
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
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.
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