FDA Class II Recall: XYLOCAINE by Fresenius Kabi USA, LLC

Key facts

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03 should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Fresenius Kabi USA, LLC. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Fresenius Kabi USA, LLC should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Fresenius Kabi USA, LLC directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

Fresenius Kabi USA, LLC’s FDA history

Argus HQ has recorded 29 total FDA actions tied to Fresenius Kabi USA, LLC: 0 warning letters, 27 recalls, 2 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the recall class for Fresenius Kabi USA, LLC's recall?

FDA classified this recall as Class II. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Why was Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 recalled?

FDA's recall record states the reason as: Presence of Particulate Matter: Hair was found in products

Who should I contact about this recall?

Contact Fresenius Kabi USA, LLC directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has Fresenius Kabi USA, LLC had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 29 total FDA actions tied to Fresenius Kabi USA, LLC, including 27 recalls and 0 warning letters.

Related enforcement actions

• Recall: Fresenius Kabi USA, LLC — Class II recall: Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose… →
• Recall: Fresenius Kabi USA, LLC — Class II recall: Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg… →
• Recall: Fresenius Kabi USA, LLC — Class II recall: Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in… →
• Recall: Fresenius Kabi USA, LLC — Class II recall: Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 2… →
• Approval: FRESENIUS KABI USA LLC — NDA approval: Unspecified (unspecified) →
• Approval: FRESENIUS KABI USA — ANDA approval: SUGAMMADEX SODIUM (unspecified) →