Mentholatum asked to explain product recall in US

Mentholatum recalled all its Rohto eye drop products, made in Viet Nam, from the United States market.

HA NOI (VNS) — The Drug Administration of Viet Nam (DAVN) has asked the Rohto-Mentholatum Viet Nam Company to give details of the entire production process of Rohto eye drop products in Viet Nam.

The request, made in a document released yesterday, comes after the company recalled all its Rohto eye drop products, made in Viet Nam, from the United States market.

The list of Rohto eye drop products for which details have been requested by DAVN, which comes under the Ministry of Health, include New V Rohto (registration number VD-20092-13); Rohto Antibacterial (registration number VD-12083-10); V Rohto For Kids (registration number VD-12084-10); V Rohto Cool (registration number VD-14100-11) and V Rohto Lycee (registration number VD-14101-11).

DAVN also asked the company to submit all documents relating to the US Food and Drug Administrations review of the production process of the Rohto-Mentholatum Viet Nam.

The HCM City Institute of Drug Quality and Control has been asked to collect and test samples of the five eye drop products and submit the report to DAVN beforeJan 28, 2014.

The Rohto-Mentholatum Company had earlier announced that it was recalling Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops made in Viet Nam after a manufacturing review, including sterility control, took place at the production facility in Viet Nam. There is no evidence yet indicating that the products do not meet the required standards. The company said the recall of the eye drops was a precautionary measure. — VNS

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