Product: Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11).    The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip.  The filled bottles are individually packaged into fiberboard cartons.
Reason for recall: Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Recall initiated: 20130909
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated