Press one of the expand buttons to see the full text of an article. Later press collapse to revert to the original form. The buttons below expand or collapse all articles.
Ontario Drug Lab Fakes Results
December 4, 2012 permalink
Fixcas recently carried a report on Annie Dookhan, a Massachusetts lab technician who faked thousands of drug tests. Now Chemi Pharmaceutical Inc in Mississauga Ontario has been found by Health Canada to have faked its tests. So far there is no news that this lab tested samples for suspected crime or child abuse. The tests were of food additives and pharmaceuticals, to qualify them for Canadian distribution.
Health Canada suspends Mississauga lab over falsified drug test results
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.
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.
Royal Gelly Power
ALPHARMA CANADA CORPORATION
BIMEDA-MTC ANIMAL HEALTH INC.
Ivermectin USP (Shandong)
Dexamethasone Base- Aventis
Methyl Paraben NF
Chlorobutanol Hemihydrate USP
Pyrantel Pamoate USP
N,Z Amine AS Casein.
Flunixin Meglumine USP
Lincomycin HCI USP
CANADIAN ANIMAL HEALTH INSTITUTE
Plutonic F-108 (Lutrol F-108)
Xylitol NF, Menthol
ODAN LABORATORIES LTD
Dairy-Free Lactase Extra Strength
Super Papaya Enzyme
SEPTA PHARMACEUTICALS INC.
THE MENTHOLATUM COMPANY OF CANADA, LTD.
Deep Relief Ice Cold Pain — Menthol products
TRILLIUM HEALTH CARE PRODUCTS INC.
Aluminum Hydroxide Gel
Natural Peppermint Flavor
Source: Toronto Star