FDA-Drug2018-08-08Class III
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
Lupin Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Sold states
Product was distributed throughout the United States
Affected count
13,896 bottles
Manufactured in
111 S Calvert St Fl 21ST, N/A, Baltimore, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1050-2018Don't want to check this manually?
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