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FDAJuly 11, 2019drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

lupin pharmaceuticalslupin

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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