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FDA recall Rohto Eye Drops - Mentholatum

  • Published
  • Public Health
The 82d AMDS Public Health Flight has received a FDA recall on the product Rohto Eye Drops - Mentholatum. The recall was initiated due to a manufacturing review at the production facility in Vietnam involving sterility controls.

Sheppard AFB did carry this item; however, it is currently on medical hold. Please check your homes for these products as they may have been sold outside of base.

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.  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.

If you are currently using this product the FDA recommends to contact the company for instructions. No reports of injury have been associated with the products at issue.

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).

Consumers who believe they have been harmed by using the eye drops should contact their primary health care provider.

For more information please visit the FDA website or contact the 82d AMDS Public Health Flight at (940) 676-8974.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm382097.htm