ISSUE WITH STERILITY CONTROLS WITHIN MANUFACTURING LEADS TO RECALL (1/16/14)

ISSUE OCCURS WITHIN VIETNAM PRODUCTION FACILITY

The Mentholatum Co. recently issued a Recall for several different eye drops that were manufactured in Vietnam.  Similar eye drops manufactured in Japan were not included within this Recall.  The Recall was initiated due to a manufacturing review at the Vietnam production facility and involved sterility controls.  The Company indicated that there exists no evidence that the product does not meet specification and that this action is strictly a precautionary measure.  It remains of interest that this represents the first Recall that has been observed originating in Vietnam. 

Recall — Firm Press Release

 The Mentholatum Company Issues Voluntary Nationwide Recall of Rohto® Eye Drops Made in Vietnam

FOR IMMEDIATE RELEASE – Orchard Park, NY – January 16, 2014 – The Mentholatum Company announced today it is conducting a voluntary recall to the retail level of Rohto® Arctic, Rohto® Ice, Rohto® Hydra, Rohto® Relief and Rohto® Cool eye drops Made in Vietnam. This recall includes ONLY lots of product that were manufactured in Vietnam and DOES NOT include eye drops made in Japan. 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. Products manufactured in Japan are not included in this recall and continue to be available to consumers.

The Mentholatum Company is initiating the recall 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; however, the company is taking this action as a precautionary measure.

The product is sold nationwide over-the-counter at pharmacies and retail stores. 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.