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)
Reported: May 14, 2025 Initiated: April 17, 2025 #D-0402-2025
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)
Reason for Recall
Presence of Particulate Matter
Details
- Recalling Firm
- Amneal Pharmaceuticals, LLC
- Units Affected
- 62 (12x100mL) bags
- Distribution
- Nationwide in the US
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Amneal Pharmaceuticals, LLC. Units affected: 62 (12x100mL) bags.
Why was this product recalled? ▼
Presence of Particulate Matter
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 14, 2025. Severity: Critical. Recall number: D-0402-2025.
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