Hong Kong Org Calls for Primrose Capsule Recall

HONG KONGThe Centre for Food Safety (CFS) of the Food and Environmental Hygiene Department in Hong Kong called on the public to stop consumption of a batch of Doctor's Choice-vening Primrose Oil, manufactured by Captek Softgel International Inc., because it was found to contain the plasticizers, di(2-ethylhexyl) phthalate (DEHP) and di-butyl phthalate (DBP).

Captek released a statement saying it is taking this event seriously and has launched an investigation to determine how this product may have been exposed to DEHP in transit or during packaging.  Further, it said it contracted an outside lab to conduct tests on eight different softgel products and none contained phthalates. We cannot control what the capsules might be exposed to either in transit to Asia or when they are packed in their final packaging assembly, said the company. Captek Softgel International has built our reputation on our ability to manufacture softgels to highest quality standards in the world and we will investigate this tirelessly to determine the root cause although we believe this to be a shipping or packaging issue at this time.

CFS said batch number OEO82OA, which comes in 40 Softgels and carries the best before date of July 28, 2013, was collected for testing at retail outlets. According to a CFS spokesman, test results showed the sample contained DEHP at a level of 2.5 parts per million (ppm) and DBP at a level of 0.86 ppm, exceeding the action levels of 1.5 ppm and 0.3 ppm adopted by the CFS respectively.

CFS noted the exposure to DEHP from the recommended daily consumption amount as stated on the product label (two softgels two to three times a day) would not exceed the Tolerable Daily Intake (TDI) set by the World Health Organization (i.e. 0.025 mg/kg of body weight). Its the same case with the exposure to DBP set by European Food Safety Authority (TDI of 0.01 mg/kg of body weight).

Even though dietary exposure estimation showed no health concern from consuming the particular product, the spokesman said as a precautionary measure, the CFS had requested the sole importer, Vita Green Health Products Co. Ltd, to immediately stop the sale and initiate recall of the relevant batch of the product. CFS also asked the public to stop consuming the product. Vita Green Health Products told the CFS that a product recall is underway.

The product was manufactured in the United States and imported to China, and CFS said it informed U.S. authorities of the test results. Earlier this year, Skyline Global Partners LLC and Prairie Capital V acquired a controlling share of Captek Softgel Inc, which Captek said would allow the company to continue to expand both operationally and geographically.

CFS said it started testing five categories of high-risk food products (sports drinks; fruit juice; tea drink; fruit jam/fruit nectar or jelly; and food in tablet, capsule or powder form) and on other relevant food products in response to a plasticizer contamination incident in Taiwan.