Moderate riskFDA DrugClass II

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

  1. Check your pharmacy or facility for vials matching lot #6133801 (expires 01/2028)
  2. Do not use affected vials
  3. Contact your supplier or Fresenius Kabi for return or replacement instructions
  4. 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.

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