December 01, 2005
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Apotex ciprofloxacin ophthalmic solution recalled

Apotex Corp. has initiated a recall of its ciprofloxacin ophthalmic solution because degradation levels may exceed the 0.2% impurity level, according to information on the Food and Drug Administration’s Web site.

Last month, Apotex sent a letter to its clients detailing the reasons for the recall; 126,790 units were affected, the company said. Specific lot numbers affected were GP1019, GP2332 and GP2334. The ophthalmic solution is indicated for topical ophthalmic use only, and was packaged in 5 mL plastic dispenser bottles, with 10 bottles per shelf pack.

The lots were distributed nationally.