Reported May 14, 2025 · Ongoing
Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals…
Amneal Pharmaceuticals, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amneal Pharmaceuticals, LLC · 400 Crossing Blvd Fl 3 · Bridgewater, NJ · 08807-2863
Is this the product you have?
- Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL)
- Manufactured byAmneal Pharmaceuticals Pvt. Ltd., Mehsana, India
- Distributed byAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)
- Lot codes and dates
Lot #'s: AL240003AL240004Exp.: 01/31/2026
- Amount recalled
- 62 (12x100mL) bags
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Presence of Particulate Matter
Using this product could cause serious injury, illness or death — stop using it now.
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