Lupin Pharmaceuticals Inc. recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimor
Recalled August 8, 2018 · FDA recall D-1050-2018 · Lupin Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study. · FDA Class III
Units
13,896 bottles
Sold at
Product was distributed throughout the United States
Description
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Product
Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →