FDA-Drug2025-05-14Class I
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)
Amneal Pharmaceuticals, LLC
Hazard
Presence of Particulate Matter
Sold states
Nationwide in the US
Affected count
62 (12x100mL) bags
Manufactured in
400 Crossing Blvd Fl 3, N/A, Bridgewater, NJ, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0402-2025Don't want to check this manually?
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