Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775
Recalled November 3, 2021 · FDA recall D-0091-2022 · Lupin Pharmaceuticals
Hazard
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration. · FDA Class III
Units
16,272 bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Product
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →