Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lup…

Recall date

July 11, 2019

Source

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

Recall number

D-1490-2019

FDA classification

Class III

Brand / firm

Lupin Pharmaceuticals Inc.

Sold / distributed

Nationwide in the U.S. and PR.

Why it was recalled

Labeling: Missing label; Product complaints reported missing bottle label.

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

What was recalled

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.