Eye Solution Recalled

Lupin Pharmaceuticals Inc is recalling 50,832 bottles of gatifloxacin ophthalmic solution for failing to meet stability specifications. According to the January 12, 2022, US Food and Drug Administration (FDA) Enforcement Report, the recall was prompted by “out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.”

The recall affects gatifloxacin ophthalmic solution 0.5% in 2.5-mL bottles (NDC 68180-435-01) from lots H003037 (Exp. 5/22), H100132 (Exp. 6/22), and H100847 (Exp. 10/22). The eye drops were manufactured by Lupin Limited, Pithampur, India, and distributed throughout the United States and Puerto Rico.

Lupin Pharmaceuticals voluntarily initiated the recall December 22, 2021. The FDA designated the recall Class III on January 4, 2022, signaling use of the affected solution is not likely to cause harm.

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