Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle,...
FDA Recall #D-1490-2019 — Class III — July 11, 2019
Product Description
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.
Reason for Recall
Labeling: Missing label; Product complaints reported missing bottle label.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
17,238 bottles
Distribution
Nationwide in the U.S. and PR.
Code Information
Lot #: H805157, Exp. 05/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated