Vietnam recalls US drugs

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Vietnam's Ministry of Health on May 4 ordered a halt to all selling of popular children's medicines following a recall by a pharmaceutical firm in the US.

Provincial health agencies were also told to "urgently" take back the drugs, including Tylenol, Zyrtec, Motrin, and Benadyl manufactured in the US.

However, the ministry said it had not approved the import of any US-made medicines into Vietnam, suspecting that some drug stores might be selling those smuggled from the US. The products legally imported into Vietnam were manufactured in Thailand, South Korea, Switzerland and Italy, the ministry said.

On April 30, McNeil Consumer Healthcare announced its voluntary recall of children's and infants' liquid products manufactured in the US including Tylenol, Motrin, Zyrtec and Benadyl.

Some of the products included in the recall may contain a higher concentration of active ingredients than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles, the company said in a press release.

According to a report issued by the US Food and Drug Administration (FDA), deficient manufacturing practices at the plant involved in the recent recall may be responsible for bacterial contamination of raw materials in the recalled products.

The report is based on a recent inspection of the McNeil Consumer Healthcare plant in Pennsylvania.

The FDA cited more than 20 manufacturing problems, including not properly testing for contamination. The report also stated that the company did not initiate "corrective and prevention action" after receiving some 46 consumer complaints regarding foreign materials in the products.

Tests

In the latest response to the issue, the Vietnam's Ministry of Health also ordered the Central Drug Examination Institute and its Ho Chi Minh City -based counterpart to take samples of the four medicines for tests.

According to the Ministry's Drug Administration of Vietnam, the products recalled in the US were not made by the same producers as those sold in Vietnam, but they will still test the medicines for active elements and the like to assure consumers.

The agency on May 4 also asked Vietnam representatives of the related pharmaceutical firms, including Janssen Cilag Ltd., GlaxoSmithKline and Pfizer Thailand Ltd., for a report on production process, and the quality and origin of materials and ingredients used.

Liquid Tylenol made by OLIC, Thailand's largest pharmaceutical manufacturer, has been sold legally in Vietnam for years as a painkiller and fever reducer.

Customers to drugstores can find liquid Tylenol in two forms: 60- milliliter bottles for children from four months old, costing VND27,000 (US$1.42) each, and droppers 15 milliliters for children up to three years old, costing VND22,000 ($1.16) each.

According to the pharmacies, Tylenol is favored by Vietnamese mothers because children don't mind the taste.

Zyrtec is sold in Vietnam as liquid or 10-milligram tablets to treat runny nose or allergies in children two and above. The liquid is made in Thailand while the tablets were imported from the Italian branch of UCB Pharma SA group.

Both Tylenol and Zyrtec were imported into Vietnam by the Central Pharmaceutical Joint-stock Company No.2 based in HCMC.

Phan Thanh Lay, general director of the company, told Thanh Nien on May 5 that the medicines recalled were made in the US and had not been distributed by the company.

In the latest import batch this January, the company shipped in more than 10,000 bottles of Tylenol, each 15 milliliters. Since 2009, the company has imported Zyrtec for four times, each time with 50,000- 100,000 tablets.

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