Rohto Eye Drops - Mentholatum: Recall - Sterility Control Review

[Posted 01/17/2014]

AUDIENCE: Consumer, Pharmacy

ISSUE: The Mentholatum Company announced a voluntary recall of Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops. The recall was initiated due to a manufacturing review at the production facility in Vietnam involving sterility controls. To date, there has been no evidence indicating that product does not meet specifications.

BACKGROUND: The products are sold nationwide over-the-counter at pharmacies and retail stores. This recall includes only lots of product that were manufactured in Vietnam. This recall affects Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops that were made in Vietnam only, which can be identified by the words "Made in Vietnam" on the side carton panel under the company name and address information, as well as on the back label of the bottle. The lot numbers for products made in Vietnam will include the letter "V," for example, "Lot 3E1V," and will be located on the bottom panel of the carton, and on the bottom of the eye drop bottle.

RECOMMENDATION: The Mentholatum Company is notifying its distributors and retailers by letter to stop distribution and follow instructions in the recall letter. Consumers that have recalled product should contact the company for instructions. Questions about this recall may be directed to The Mentholatum Company Customer Service Department at 1-877-636-2677 Monday – Friday 9 AM to 5 PM (EST).

[01/16/2014 - Press Release - Mentholatum]