Otic Unapproved Prescription Preparations Containing Benzocaine or Chloroxylenol
Last Updated: July 28, 2015
Products Affected - Description
Unapproved prescription otic products containing:
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.
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.
- Acetylcholine Chloride Powder for Intraocular Solution — Current
- Becaplermin Gel — Resolved
- Boceprevir Capsules — No Longer Available
- Cardioplegic Solution for Cardiac Perfusion — Current
- Castor Oil, Balsam Peru, and Trypsin Topical Products — No Longer Available
- Chloroquine Tablets — Current
- Dexpanthenol Injection — Current
- Diatrizoate Meglumine 66% and Diatrizoate Sodium 10% — Resolved
- Erythromycin Ethylsuccinate and Sulfisoxazole Oral Suspension — No Longer Available
- Ezetimibe and Atorvastatin Tablets — No Longer Available
- Fluticasone/Salmeterol Inhalation Aerosol (Advair HFA) — Resolved
- Gabapentin Enacarbil Extended Release Tablets — Resolved
- Gadoteridol Injection — Current
- Hydroxychloroquine Sulfate Tablets — Resolved
- Iopamidol Injection — Resolved
- Levothyroxine (Levothroid) Oral Tablets — No Longer Available
- Prenatal Multivitamins with Minerals — No Longer Available
- Rifampin and Isoniazid Capsules — Resolved
- Trypan Blue 0.15% Ophthalmic Solution — Resolved
- Warfarin for Injection — No Longer Available
July 28, 2015, University of Utah, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.