FDA-Drug2017-03-15Class III
Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05
Actavis Inc
Hazard
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Sold states
Nationwide
Affected count
14280 bottles
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0514-2017Don't want to check this manually?
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