Actavis Inc recalls Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co…

Recall date

February 7, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0514-2017

FDA classification

Class III

Brand / firm

Actavis Inc

Sold / distributed

Nationwide

Why it was recalled

Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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