FDA recall D-1039-2014

Product

ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01096 1, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.

Reason for recall

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-01-16

Report date

2014-02-05

Termination date

2018-06-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orchard Park, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1039-2014