Fresenius Kabi USA, LLC — Class II: Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL),
Fresenius Kabi USA, LLC has initiated a Class II recall for Naropin (ropivacaine hydrochloride Injection, USP) 0.5% due to the presence of particulate matter, specifically hair found in the product.
This affects Fresenius Kabi USA, LLC, healthcare facilities utilizing Naropin single-dose vials, and pharmaceutical quality and manufacturing personnel responsible for sterile injectable oversight.
A Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences. The presence of organic particulate matter like hair suggests a potential breach in sterile manufacturing processes or environmental controls, which may necessitate an internal investigation into gowning procedures or cleanroom integrity.
QA teams should verify current inventory against the specified NDC tray and vial numbers. Manufacturing leads should review gowning protocols and cleanroom environmental controls to mitigate risks of intrinsic particulate contamination.
Class II. Reason: Presence of Particulate Matter: Hair was found in products. 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. Firm: Fresenius Kabi USA, LLC (Lake Zurich IL United States). Status: Ongoing.
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