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.

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Health Canada suspends Mississauga lab over falsified drug test results

Published December 4, 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

Source: Toronto Star