Ropivacaine Hydrochloride Injection Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Ropivacaine Hydrochloride Injection USP 0.5% nationwide due to incomplete stability studies. The manufacturer ceased operations and could not continue required FDA testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA drug recall without reported illnesses or injuries, and the hazard is theoretical (incomplete stability studies) rather than an identified defect or contamination. The recall is precautionary in nature due to the manufacturer's business closure.
Plain-English summary
Akorn, Inc. is recalling all lots of Ropivacaine Hydrochloride Injection USP, 0.5%, 150 mg/30 mL (5 mg/mL), 30 mL single-dose vials, distributed nationwide in the USA and Puerto Rico.
The recall is due to CGMP deviations: the manufacturer went out of business and could no longer continue the stability studies required by the FDA. These studies are necessary to demonstrate that the drug maintains its safety and effectiveness throughout its shelf life.
The product is a prescription local anesthetic injection. All lots manufactured by Akorn, Inc. are affected. Healthcare providers should contact Akorn regarding inventory management and appropriate disposition of existing stock. Patients should consult their healthcare provider if they have questions about this recall.
The recalled product
- Product
- Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Hazard
- cgmp-deviation
- incomplete-stability-studies
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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