Drug 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)
D-0402-2025
Product summary
- Event
- Event 96648
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 62 (12x100mL) bags
- Official record key
drug-enforcement:D-0402-2025
Official wording
Reason: Presence of Particulate Matter
Code information: Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
Distribution pattern: Nationwide in the US
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter