FDA recall D-0402-2025

Amneal Pharmaceuticals, LLC · Class I · drug

Product

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

Nationwide in the US

Key facts

Status: Ongoing
Initiation date: 2025-04-17
Report date: 2025-05-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0402-2025