20121205/密市化验公司涉造假遭停牌 至少53种产品须重验

(多伦多4日加新社电)密西沙加(Mississauga)1间化验公司涉嫌造假,本周被加拿大卫生部停牌。卫生部称,它在该公司涉及的大量产品检测中发现不实结果,其中包括药物及健康食品,目前已确认至少53种产品需重新化验。

卫生部说,一些个案中,克米医药公司(Chemi Pharmaceutical Inc.)未有检验成品或原材料。这些虚假检验结果,被提供给与克米公司有服务合约的公司。

卫生部收到线报后展开调查。机构周二时说,它已要求那些使用克米进行质素检验的公司,停止销售受影响产品,直到其安全性获得证实。

卫生部称,没有证据显示国民的健康受到威胁。

克米公司总裁斯塔里科夫(Mariana Stavrikov)说,确实有人假造纪录,但并非公司,而是一名雇员所为,当事人已被解雇。

斯塔里科夫说,那名男子承认,是他向卫生部提供线索。

她拒绝说出男子姓名,仅称他不是长期雇员,是该公司24名雇员之一。

卫生部健康产品及食物部门助理副部长格洛弗(Paul Glover)说,克米涉及的产品检测很广泛。

他说,卫生部迄今找出至少53种产品,需要重新化验,它也在等候制造商关于另外25种产品的回应,它们可能也需再度检验。

民众可到卫生部网站,查看一份需要重新化验的产品清单。

重验产品包括高血压糖尿药

卫生部的斯图尔特医生(John Patrick Stewart)说,克米的检测工作中,仅少量是检测即将上市的成品。他说,清单内包括少量处方药,有些用来控制高血压与糖尿病。

格洛弗说,该公司的牌照周一被吊销,事宜已知会皇家骑警。

他说,根据《食物及药品法》(Food and Drug Act),假造纪录、或者有导致产品对消费者不安全的行为,都是刑事罪行。一名卫生部官员称,如果罪名成立,每项控罪可处最高罚款5,000元及3年刑期。

Health Canada suspends Mississauga lab over falsified drug test results

Published on Tuesday December 04, 2012

Jeff Green Staff Reporter

Health Canada says a Mississauga chemical testing laboratory falsified results in tests of food additives and pharmaceuticals including generic aspirin.

The lab, Chemi Pharmaceutical Inc., has had its licence suspended and Health Canada has halted sales of 53 products that need to be retested.

“In some cases the testing was not done at all, or it was done and the results — or the so-called results — were sent to the client before the testing was done,” said Sean Upton, a spokesperson for Health Canada.

The agency added that there is no indication anyone has become sick because of the falsified results.

Chemi said an employee who has since been fired is to blame.

The list of products identified by Health Canada is wide ranging. Some of the drugs included were from a Pfizer subsidiary to be used in pig and poultry feed; hypertension medications from Septa Pharmaceuticals; a generic form of aspirin produced by Quebec-based Pharmalab; and Deep Relief Ice Cold Pain.

Health Canada inspectors initially had concerns after a routine inspection at Chemi in October, and said they would be back for a surprise visit. Before they returned, a tip about falsified results came in on Nov. 21. The inspectors discovered the problems over the following two days.

Chemi president Mariana Stavrikov said the records were falsified by an employee who has been fired. She said he was not a longtime employee at the firm of 24 workers, but she would not identify him.

Stavrikov, who runs the company with her husband Emil, said the tipster was the person who falsified the tests.

“All the results that had been falsified were done by him … What this shows is that one sabotager can sabotage the system,” Stavrikov said. “The products are safe. We’ve committed to retest all (the products).”

At least one company, Septa Pharmaceuticals, has cut ties with Chemi.

“Based on the notice we received from Health Canada (Monday) night, we have immediately ceased any relationship with Chemi Pharmaceutical and we are in the process of qualifying a new testing laboratory,” said CEO Devinder Kumar in a statement.

Health Canada said it has informed the RCMP about the falsified results and is now working to ensure none of the products reach the market without their final tests.

With files from The Canadian Press

List of products tested by Chemi Pharmaceutical

As a precaution, companies that have had testing done by Chemi Pharmaceutical are being asked to temporarily halt sales of those products until their safety can be confirmed. Below is a list of products and substances that are affected by this request.

ACCUREX HEALTH CARE MANUFACTURING INC.

Bee Propolis

Royal Gelly Power

ALPHARMA CANADA CORPORATION

Avatec

Bovatec

Robenz

BIMEDA-MTC ANIMAL HEALTH INC.

Ivermectin USP (Shandong)

Dexamethasone Base- Aventis

Benzyl Alcohol

Methyl Paraben NF

Oxytocin USP

Chlorobutanol Hemihydrate USP

Pyrantel Pamoate USP

Choline Chloride

Sorbitol Solution

Phenylbutazone

Clorsulon

N,Z Amine AS Casein.

Flunixin Meglumine USP

Oxytetracycline Dihydrate

Xylazine

Lincomycin HCI USP

Butamben USP

Povidone

CANADIAN ANIMAL HEALTH INSTITUTE

Aspirin

GERMIPHENE CORPORATION

Plutonic F-108 (Lutrol F-108)

PEG-400,

Tween 80,

Aerosol 200,

Urea

Propylene Glycol

Xylitol NF, Menthol

ODAN LABORATORIES LTD

Asatab

PHARMALAB

Dairy-Free Lactase Extra Strength

Ergoloid Mesylates

Hydergine

Aspirin

Super Papaya Enzyme

SEPTA PHARMACEUTICALS INC.

Septa-Atenolol

Septa- Amlodopine

Septa- Ciprofloxacin

Septa-Ondansetron

STERIMAX INC.

Orphenadrine Citrate

Hydergine

NHP: Lactomax

THE MENTHOLATUM COMPANY OF CANADA, LTD.

Provacare

Deep Relief Ice Cold Pain — Menthol products

TRILLIUM HEALTH CARE PRODUCTS INC.

Methylparaben Sodium

Sodium Alginate

Cetylpyridinium Chloride

Xanthan Gum

Aluminum Hydroxide Gel

Natural Peppermint Flavor

Calcium Carbonate

http://www.thestar.com/news/canada/politics/article/1297401–health-canada-suspends-mississauga-lab-over-test-results