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7/28/2016

Ofloxacin Otic Solution

Products Affected - Description

    • Ofloxacin otic solution, Apotex, 0.3%, 10 mL bottle, 1 count, NDC 60505-0363-02
    • Ofloxacin otic solution, Apotex, 0.3%, 5 mL bottle, 1 count, NDC 60505-0363-01
    • Ofloxacin otic solution, Sandoz, 0.3%, 10 mL bottle, 1 count, NDC 61314-0015-10
    • Ofloxacin otic solution, Sandoz, 0.3%, 5 mL bottle, 1 count, NDC 61314-0015-05

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

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.

Updated

Updated July 28, 2016 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 25, 2015 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2017, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 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, with 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 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 ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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