FDAHealthApril 17, 2025
Amneal Pharmaceuticals, LLC — Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal P
⚠️ Presence of Particulate Matter
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 17, 2025
Nationwide in the US
What's affected?
- Product
- 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)
- UPC
- 0370121173533
- Lot code
- 's:
Additional details
Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 62 (12x100mL) bags.
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