Fresenius Kabi USA, LLC: Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fre
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Fresenius Kabi USA, LLC
- Product
- Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05
- Reason / hazard
- Presence of Particulate Matter: Hair was found in products
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide within in the USA
- Recall initiated
- 2026-07-16
- Code info
- Lot #: 6133436, Exp. Date 10/2028
- Product quantity
- 92,600 vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Lake Zurich
- State
- IL
- Country
- United States
- Event id
- 99449
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