Recall D-0402-2025

US Class I Ongoing · initiated 2025-04-17

Recalling firm

Amneal Pharmaceuticals, LLC, NJ

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

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