Akorn recalls all 30mL single-dose ropivacaine injection vials due to company closure preventing stability testing. This affects prescription-only medical use.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all single-dose ropivacaine injection vials because the company went out of business and can no longer perform stability testing. This means the medication may not be safe for use after the expiration date.
The manufacturer went out of business and can no longer conduct stability studies. This means the product's safety and effectiveness over time cannot be verified, potentially leading to medication failure or adverse reactions.
Prescription patients using this specific ropivacaine injection vial. Healthcare providers who have this product in their inventory are most at risk.
Check for Akorn, Inc. manufactured ropivacaine hydrochloride injection vials labeled 0.5%, 150mg/30mL (5mg/mL), 30mL single-dose. All lots and all NDC numbers are affected.
Verify the product label matches the recalled vial description: 0.5% ropivacaine hydrochloride injection, 150mg/30mL, 30mL single-dose vial.
The recall states the manufacturer went out of business and can no longer perform stability testing, so safety cannot be confirmed. Do not use this product.
Check for Akorn, Inc. manufactured ropivacaine hydrochloride injection vials labeled 0.5%, 150mg/30mL (5mg/mL), 30mL single-dose. All lots and all NDC numbers are affected.
The recall does not specify a remedy, so contact your healthcare provider or pharmacy for guidance on safe disposal or alternatives.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0842-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0842-2023 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
