FDA-Drug2019-03-06Class III
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.
Lupin Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Sold states
Nationwide in the USA and Puerto Rico.
Affected count
674,628 bottles
Manufactured in
111 S Calvert St Fl 21ST, Baltimore, MD, United States
Products
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, 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-0517-2019Don't want to check this manually?
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