Drug recall D-1848-2019

Class III Terminated reported Sep 18, 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.

Lots and codes

Lot GABH0003, EXP 7/2020

Recall details

Recalling firm
Mylan Pharmaceuticals Inc., Morgantown, WV
Quantity
13,157 5 mL bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
September 6, 2019
Terminated
July 16, 2020