Status
Ongoing
Drug Enforcement D-0402-2025
Presence of Particulate Matter
Classification
Class I
Report Date
May 14, 2025
Termination Date
—
Product Information
- Product description
- 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)
- Product quantity
- 62 (12x100mL) bags
- Reason for recall
- Presence of Particulate Matter
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the US
Location & Firm
- Recalling firm
- Amneal Pharmaceuticals, LLC
- Address
-
400 Crossing Blvd Fl 3, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0402-2025
- Event ID
- 96648
- Recall initiation date
- April 17, 2025
- Center classification date
- May 5, 2025
- Code info
- Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
- More code info
- —