Ropivacaine Hydrochloride Injection
FDA Recall NDC 70121-1735
Latest: Class I · Status: Completed · Initiated Apr 17, 2025 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ropivacaine Hydrochloride (NDC 70121-1735). A significant event, classified as Class I, was initiated on Apr 17, 2025 by Amneal Pharmaceuticals Llc. The reported reason for this action was: "Presence of Particulate Matter"
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Completed
Presence of Particulate Matter
Apr 17, 2025
May 14, 2025
62 (12x100mL) bags
Recall Profile & Regulatory Data
Event ID
96648
Classification
Class I
Enforcement Status
Completed
Recalling Firm
Amneal Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)
Batch or Lot Expiration Information
Lot# 's: AL240003, AL240004, Exp.: 01/31/2026
Affected Packages Involved in this Recall
70121-1732-9Ropivacaine Hydrochloride
70121-1732-3Ropivacaine Hydrochloride
70121-1733-9Ropivacaine Hydrochloride
70121-1733-3Ropivacaine Hydrochloride
70121-1734-7Ropivacaine Hydrochloride
70121-1734-3Ropivacaine Hydrochloride
70121-1735-7Ropivacaine Hydrochloride
70121-1735-3Ropivacaine Hydrochloride
70121-1734-1Ropivacaine Hydrochloride
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
