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Author Topic: Herbal injection recall list expanded  (Read 616 times)
skyjet
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« on: October 19, 2008, 11:41:50 PM »

2008-10-20

The Chinese producer of the deadly "ciwujia" herbal injection decided on Friday to recall all its injection products, expanding its previous recall list, the national drug safety watchdog said Saturday.

The Ministry of Health and the State Food and Drug Administration (SFDA) said in a statement issued on Saturday the Wandashan Pharmaceutical Company, in the northeastern HeilongjiangProvince, initiated the move "voluntarily" according to the country's drug recall regulations.

The regulations stipulated drug manufacturers should analyze collected information. They should also make investigations and evaluations on drugs with possible hidden safety problems; decisions were required to recall products once hidden safety problems were spotted.

The SFDA also issued a notice to suspend sales and medical use nationwide of all injection products manufactured by the company on Friday.

It ordered its local branches to monitor the recall to make sure these drugs were pulled off shelves and to gather data on any adverse reactions caused by them.

Before the announcement, the administration had ordered the company to recall all its herbal injection products and report the progress on a daily basis.

Six patients in the southwestern Yunnan Province experienced adverse reactions after receiving a ciwujia injection. Their symptoms included vomiting and becoming comatose. Three patients died, according to a report released on Oct. 6. The other three remain under observation.

The medicine is extracted from ciwujia, a type of Siberian ginseng. Injections are often used to treat thrombosis caused by a weak liver and kidneys. It is also believed to be helpful in treating coronary heart disease, nervous exhaustion and menopausal problems.

Testing on ciwujia samples showed the product was tainted with bacteria, said the Ministry of Health and the SFDA earlier this week.

An investigation is underway to determine how contamination happened.
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