FDA recall D-1050-2018

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 for recall

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

Key facts

Status

Terminated

Initiation date

2018-07-26

Report date

2018-08-08

Termination date

2019-12-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1050-2018