Class I
Ongoing
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)
This recall is currently active, issued May 14, 2025. It was issued by Amneal Pharmaceuticals, Llc.
- Company
- Amneal Pharmaceuticals, Llc
- Recall Initiated
- April 17, 2025
- Posted
- May 14, 2025
- Recall Number
- D-0402-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 62 (12x100mL) bags
- Firm Location
- Bridgewater, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Particulate Matter
Distribution
Nationwide in the US
Lot / Code Info
Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
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