Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amne...
FDA Recall #D-0402-2025 — Class I — April 17, 2025
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)
Reason for Recall
Presence of Particulate Matter
Recalling Firm
Amneal Pharmaceuticals, LLC — Bridgewater, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
62 (12x100mL) bags
Distribution
Nationwide in the US
Code Information
Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated