Actavis Inc recalls Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal C
Recalled March 15, 2017 · FDA recall D-0514-2017 · Actavis
Hazard
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point. · FDA Class III
Units
14280 bottles
Sold at
Nationwide
Description
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Product
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
Manufacturer(s)
Actavis Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →