July 25, 2019
Lupin Pharmaceuticals Inc. is recalling a single lot of gatifloxacin ophthalmic solution 0.5% due to complaints of missing product labels, according to the July 24, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects gatifloxacin ophthalmic solution 0.5% in 2.5-mL bottles (NDC 68180-435-01) from lot H805157 (Exp. 5/20). The bottles were distributed in the United States and Puerto Rico.
Lupin Pharmaceuticals voluntarily initiated the recall July 11, 2019. The FDA designated the recall Class III on July 17, 2019. Under the recall classification, use of the affected medication is not likely to cause harm.
Gatifloxacin ophthalmic solution 0.5% is a prescription fluoroquinolone antibiotic used to treat pinkeye and other eye infections.