The Recall Desk
HighFDA (Drugs)·D-1052-2022·Announced 2022-06-15

Xylocaine injectable anesthetic recalled for temperature abuse during manufacturing

McKesson Medical-Surgical is recalling Xylocaine injectable vials nationwide due to temperature abuse during manufacturing and distribution. This local anesthetic is used for medical and dental procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The temperature abuse could potentially affect drug stability and sterility, but no adverse outcomes have been reported. Per the rubric, recalls involving risk-of-harm products without reported injuries are classified as High.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling Xylocaine (lidocaine hydrochloride 1% with epinephrine bitartrate) multi-dose vials due to cGMP deviations involving temperature abuse. The recalled product consists of 76 trays containing 25 vials each and was distributed nationwide to healthcare facilities and medical and dental providers. Temperature abuse could compromise the sterility, stability, and potency of this injectable anesthetic.

Xylocaine is used for local anesthesia via infiltration and perineural (nerve block) procedures in medical, surgical, and dental settings. Healthcare facilities should review their records using the dates provided in notification letters sent by McKesson. Because the firm cannot identify specific lot numbers by customer, each notification includes the date product was distributed and the dates when affected product may have been shipped. Facilities with potentially affected product should quarantine it and contact McKesson or their supplier for further instructions.

The recalled product

Product
XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
Brand
XYLOCAINE
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Injectable Anesthetic
Hazard
  • temperature-exposure
  • stability-loss
  • sterility-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

UPCs (14)

  • 0363323484576
  • 0363323485016
  • 0363323483036
  • 0363323487072
  • 0363323486013
  • 0363323495091
  • 0363323488079
  • 0363323489021
  • 0363323495046
  • 0363323491017
  • 0363323492045
  • 0363323492090
  • 0363323482015
  • 0363323481018

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · XYLOCAINE

Same category