Home / Recalls / Amneal Pharmaceuticals, LLC / D-0402-2025

D-0402-2025 Class I Ongoing

Recalled by Amneal Pharmaceuticals, LLC — Bridgewater, NJ

Recall Details

Product Type: Drugs
Report Date: May 14, 2025
Initiation Date: April 17, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 62 (12x100mL) bags

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

Distribution Pattern

Nationwide in the US

Code Information

Lot #'s: AL240003, AL240004, Exp.: 01/31/2026

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