Eye Drops Recalled

Lupin Pharmaceuticals Inc is recalling 16,272 bottles of gatifloxacin ophthalmic solution for failing to meet stability specifications, according to the November 3, 2021, 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 H002512 (Exp. 3/22). The solution was manufactured by Lupin Limited, Pithampur, India, and distributed throughout the United States and Puerto Rico.

Lupin Pharmaceuticals voluntarily initiated the recall October 20, 2021. The FDA designated the recall Class III on November 2, 2021. Under the recall classification, use of the affected solution is not likely to cause harm.

Gatifloxacin ophthalmic solution is available with a prescription to treat bacterial conjunctivitis.