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
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)
Reason for the Shortage
- Apotex discontinued ofloxacin otic solution in early-2015.
- Sandoz discontinued ofloxacin otic solution in mid-2015.
- Valeant cannot provide a reason for the shortage.
There are no presentations available.
Estimated Resupply Dates
Valeant has temporarily discontinued ofloxacin otic 5 mL and 10 mL vials. The company cannot estimate a release date.
- 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.
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.
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