Recall: D-1050-2018

Class III - Minor Violations

Class IIIClassification

2018-07-26Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

Product

Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01

Reason

Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.

Distribution

Product was distributed throughout the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.