FDA recall D-1848-2019

Product

Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35

Reason for recall

Failed Impurities/Degradation Specifications:OOS for unknown impurity.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-09-06

Report date

2019-09-18

Termination date

2020-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1848-2019