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Ofloxacin Otic Solution

[28 July 2016]

Products Affected - Description

Ofloxacin otic solution, Sandoz
0.3%, 5 mL bottle, 1 count (NDC 61314-0015-05) - discontinued
0.3%, 10 mL bottle, 1 count (NDC 61314-0015-10) - discontinued

Reason for the Shortage

  • Apotex discontinued ofloxacin otic solution in early-2015.
  • Sandoz discontinued ofloxacin otic solution in mid-2015.
  • Valeant could not provide a reason for the shortage.

Available Products

Ofloxacin otic solution, Valeant
0.3%, 5 mL bottle, 1 count (NDC 24208-0410-05)
0.3%, 10 mL bottle, 1 count (NDC 24208-0410-10)

Estimated Resupply Dates

Valeant has ofloxacin otic 5 mL and 10 mL vials available.

Safety

  • Ophthalmic drops can generally be used in the ears; however, otic drops should never be used in the eyes. Ophthalmic drops cannot automatically be substituted for otic drops; prescribers must specifically indicate this on the prescription.
  • Ofloxacin ophthalmic and otic drops have similar inactive ingredients except for the concentration of benzalkonium chloride is 0.005% in the ophthalmic solution and 0.0025% in the otic formulation.
  • The dosage and administration of ofloxacin is significantly different between the otic and ophthalmic routes.

Related Shortages

Updated

July 28, April 29, February 1, 2016; October 26, September 14 and 9, August 4, July 10, June 25, 2015, University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Vizient, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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