FDA-Drug2019-02-20Class III
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01
Lupin Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Sold states
Product was distributed by 5 wholesalers, 6 drug chains, 4 mail order pharmacies and 1 mail order pharmacy/supermarket who may have further distribute the product throughout the United States.
Affected count
43,860 3ml bottles
Manufactured in
111 S Calvert St Fl 21ST, N/A, Baltimore, MD, United States
Products
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 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-0484-2019Don't want to check this manually?
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