Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01

Recall Number: D-0484-2019

Firm: Lupin Pharmaceuticals Inc.

Classification: Class III

Status: Terminated

Report Date: 20190220

Initiation Date: 20190201

Termination Date: 20200626

Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.

Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01