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Chinese Herbal Injection Recalled in Infant Death Probe

Chinese health authorities are recalling a herbal injection that was suspected to have led to the death of a newborn baby and some adverse effects in another three.

A 9-day-old baby in northwest China's Shaanxi Province died on October 11, after being injected with "Yinzhihuang", an injectable remedy containing extracts of herbs, including gardenia and honeysuckle. The drug is widely used, orally and intravenously, in Chinese hospitals to treat liver diseases and infantile jaundice.

The baby was hospitalized at Zhidan County Hospital in the city of Yan'an before he died.

The Ministry of Health confirmed in a teleconference on Sunday that three other newborn babies in the hospital had "adverse effects" after receiving the injection, and told hospitals across the country to stop using the drug.

The ministry didn't specify the symptoms of the affected infants.

Taihang Pharmaceutical, the Shanxi-based producer of the drug, put an emergency notice on its website on Monday, saying it had launched a recall of a batch of products on October 16, the day it was informed of the death.

The company said it had submitted a report on October 17 to all hospitals and drug stores that sold the drug and to the Shanxi provincial drug safety watchdog.

It said the suspect batch of drug was produced in October 2007 and 260,000 bottles had been sold in eight provinces: Hebei and Shanxi in the north, Jilin and Heilongjiang in the northeast, Shandong in the east and Shaanxi, Yunnan and Ningxia Hui Autonomous Region in the west.

No adverse effects had yet been reported in the other seven provinces.

Samples of the drug are being tested at an institute of the Shanxi provincial drug safety watchdog, and the results would be not known for at least 10 days.

Bacteria contamination in another injectable herbal product was blamed for three deaths in the southwestern Yunnan Province on October 6.

The problematic product, known as Ciwujia, is processed from a type of Siberian ginseng produced by Wandashan Pharmaceutical Co. based in the north China's province of Heilongjiang. The State Food and Drug Administration has ordered recalls or confiscations of the drug.

(Xinhua News Agency October 21, 2008)

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