FDAFDA · Food and drugs·Recall number D-0402-2025
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)
Published May 14, 2025 · Recall initiated: April 17, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ROPIVACAINE HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Distributor
- Nationwide in the US
- UPC
- 0370121173533
- Lot
- Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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