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Class II: temporary or reversible health riskOngoing

Akorn Ropivacaine Hydrochloride Injection Recall

Ropivacaine Hydrochloride Injection USP, 0

Akorn, Inc. · Gurnee, IL

Risk level
Class II
Reported by FDA
Jun 7, 2023
Recall ID
D-0842-2023
Check your lot numberHow we source this data

Summary

Akorn recalled Ropivacaine Hydrochloride Injection starting Apr 26, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0842-2023 on Jun 7, 2023. Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies. Status: Ongoing.

Why it was recalled

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Product description

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

Lot numbers, UPCs & expiration codes

All Lots

Where it was sold

Nationwide in the USA and Puerto Rico

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0842-2023
Classification
Class II
Status
Ongoing
Recall initiated
Apr 26, 2023
FDA report date
Jun 7, 2023
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
Akorn, Inc.

Original FDA data

Every field from FDA enforcement report D-0842-2023, exactly as published.

Show all FDA fields
City
Gurnee
State
IL
Status
Ongoing
Country
United States
Event ID
91788
Address
5605 Centerpoint Ct Ste A
Code information
All Lots
Postal code
60031-5278
Report date
Jun 7, 2023
Product type
Drugs
Recall number
D-0842-2023
Classification
Class II
Recalling firm
Akorn, Inc.
Reason for recall
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide in the USA and Puerto Rico
Recall initiation date
Apr 26, 2023
Initial firm notification
Letter
Center classification date
Jun 1, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0842-2023, published Jun 7, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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