Product: 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
Reason for recall: Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Recall initiated: 20190201
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated