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Otic Unapproved Prescription Preparations Containing Benzocaine or Chloroxylenol

Last Updated: July 28, 2015
Status: Discontinued

Products Affected - Description

Unapproved prescription otic products containing:
      Benzocaine
      Benzocaine and antipyrine
      Benzocaine, antipyrine, and zinc acetate
      Benzocaine, chloroxylenol, and hydrocortisone
      Chloroxylenol and pramoxine
      Chloroxylenol, pramoxine, and hydrocortisone

Reason for the Shortage

  • FDA is taking enforcement on all unapproved prescription otic products.
  • FDA-approved prescription otic products and legally marketed Over-The-Counter otic products are not affected.

Available Products

No FDA approved otic preparations containing either benzocaine or chloroxylenol are available.

Estimated Resupply Dates

There are no FDA-approved otic presentations containing benzocaine or chloroxylenol available. Some unapproved products may be available until supplies are depleted.

Related Shortages

Updated

July 28, 2015, University of Utah, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.

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