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

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