Fresenius Kabi lidocaine injection recalled for hair contamination
Hair was found in Fresenius Kabi Lidocaine HCl Injection vials (2%, 20 mg per mL). This affects 181,225 vials nationwide with lot number 6133801 and an expiration date of January 2028. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Fresenius Kabi recalls
What to do
- Check your pharmacy or facility for vials matching lot #6133801 (expires 01/2028)
- Do not use affected vials
- Contact your supplier or Fresenius Kabi for return or replacement instructions
- Report any use of contaminated vials to your healthcare provider or pharmacist
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 5 products — see all of them.
Details
- Units affected
- 181,225 vials
- Illnesses reported
- None reported
- Manufactured in
- 3 Corporate Dr, N/A, Lake Zurich, IL, United States
- Classification
- Class II
- Recall number
- D-0726-2026
In the FDA's words
- Description
- Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01 Presence of Particulate Matter: Hair was found in products Lot #: 6133801, Exp. Date 01/2028 Distribution: Nationwide within in the USA Affected quantity: 181,225 vials
- Hazard
- Presence of Particulate Matter: Hair was found in products
5 products in this recall
Fresenius Kabi Xylocaine, Naropin and more recalled over hair
Fresenius Kabi is recalling five injectable medicine products because hair was found in some vials. The products are Xylocaine (two sizes), Naropin, lidocaine HCl injection and glycopyrrolate injection, all made by Fresenius Kabi in Lake Zurich, Illinois, and sold nationwide. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL…D-0725-2026 · 59,425 vials
- Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 600… (this page)D-0726-2026 · 181,225 vials
- 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…D-0727-2026 · 92,600 vials
- Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich,…D-0728-2026 · 93,250 vials
- 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,…D-0729-2026 · 37,250 vials
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