FDA recall D-1490-2019

Product

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.

Distribution

Nationwide in the U.S. and PR.

Key facts

Status

Terminated

Initiation date

2019-07-11

Report date

2019-07-24

Termination date

2020-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1490-2019