Eye Drops Recalled Over Sterility Concerns at Manufacturing Plant

Mentholatum-Company-Eye-Drop-Sterility-RiskThe U.S. Food and Drug Administration (FDA) just  announced that the Mentholatum Company has initiated a voluntary recall of its Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to sterility concerns at a production facility in Vietnam.

The recall followed a manufacturing review at the Vietnam production facility that raised concerns about sterility controls.

The eye drops, over-the-counter (OTC) products, are sold nationwide at pharmacies and retail stores. The recall involves only eye drops that were manufactured in Vietnam.  The affected products are:

  • Rohto Arctic
  • Rohto Ice
  • Rohto Hydra
  • Rohto Relief
  • Rohto Cool

The words “Made in Vietnam” appear on the product’s side carton panel below the company’s name and address information and also appear on the back label of the bottle. Drops manufactured in Vietnam have the letter V in their lot number: for example, Lot 3E1V. The lot number is printed on the bottom panel of the carton and also on the bottom of the eye drop bottle.

The Mentholatum Company notified distributors and retailers by letter to stop distribution and sale of the affected eye drops. The letter contains instructions for how to handle recalled products. Consumers with bottles of the recalled drops should contact the the Mentholatum Company Customer Service Department, toll free, at 1.877.636.2677, Monday to Friday, 9:00 a.m. to 5:00 p.m. (EST).

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