Parker Waichman LLP

Blood Thinner Lovenox Recalled Over Contamination Concerns

French health authorities have just ordered the recall of 11 batches of Sanofi-Aventis’ anti-clotting drug Lovenox.  The withdrawal is taking place as a precautionary measure over concerns about a possible contamination.  France’s Health Products Safety Agency said the 11 batches showed abnormally high levels of over-sulphated chondroitin sulphate in one of the drug’s ingredients. Levels […]

French health authorities have just ordered the recall of 11 batches of Sanofi-Aventis’ anti-clotting drug <"https://www.yourlawyer.com/practice_areas/defective_drugs">Lovenox.  The withdrawal is taking place as a precautionary measure over concerns about a possible contamination.  France’s Health Products Safety Agency said the 11 batches showed abnormally high levels of over-sulphated chondroitin sulphate in one of the drug’s ingredients.

Levels of the contaminant were “much lower” than those found in recent cases of contaminated Heparin in the United States and Germany, the agency added; however, similar recalls have also occurred in Sweden, Australia, and Spain.

In the US, reports of serious reactions linked to Heparin numbered over 700 with an estimated 21 deaths.  Baxter International, Inc., recalled virtually all of its Heparin products in the US; at the time, companies in Germany and Japan also recalled their Heparin products.

Heparin is a blood thinner administered in surgery and other critical care areas to prevent blood clots, is crucial in dialysis and heart surgery, and is used for the bedridden.  Other drugs thin blood, but their effects are not as quick or as easily reversed.  Heparin, which has been manufactured since 1930, is administered to millions of patients yearly and although Heparin has been used safely by millions of Americans, the bad batch of the drug sickened hundreds and killed dozens because it contained a contaminated ingredient that remains under investigation.  The batch was made in China.

Heparin investigators were focusing efforts on recalled products that contained a contaminant that mimicked the drug’s key ingredient and were investigating whether the possible counterfeit was responsible.  Since the key ingredient came from China, fears about the integrity of exports from China and the adequacy of inspections by the FDA were heightened, prompted congressional hearings.

“I don’t think the pharmaceutical industry knows what it’s doing in China and I don’t think the US government knows what it’s doing in China,” said Michael Santoro, a Rutgers University business professor who has written about the drug industry’s business in China.  Santoro said the Baxter recalls show the need for serious restrictions on Chinese drug imports.

The FDA admitted it violated its own policy by failing to inspect the Chinese plant that manufactured the Baxter Heparin prior to shipping the Heparin ingredient to Baxter in 2004; China’s drug agency did not inspect the plant.  Also, the agency sent inspectors to the plant and found a failure to properly follow the steps for identifying impurities and deficiencies related to manufacturing equipment and, according to an inspection report released by the agency, the SPL plant appeared to have made at least some Heparin with “material from an unacceptable workshop vendor.”

Germany’s drug regulator, the Federal Institute for Drugs and Medical Devices, also issued a recall for supplies of the blood thinner Heparin after severe allergic reactions to the drug were reported; an additional warning for dialysis patients was also issued.  “We urgently suspect that they (the drugs) may be contaminated,” said Axel Thiele from the German regulator.  Thiele also said Germany experienced about 80 cases of allergic reactions linked to heparin that included breathing problems, accelerated heart beat, and low blood pressure.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Although this process has been long, I have been very fortunate to have Christina Morace assigned to my claim. From the beginning, she has been able to answer all of my questions and lead me along through the process of submitting documents. She answers all questions whether by phone or email in a timely manner. Tina is extremely professional and has a very personal manner in dealing with the complicated aspects of the WTC Victims Compensation Fund claim. I feel totally comfortable with her and highly recommend her to any other claimants who may be going through this process.
T-J Fleming
2 years ago
5 Star Reviews 150
The best lawyer company I have ever met, very attentive, very concerned about my case, especially Jorge Peniche, who helped me with everything with my medication, my therapy, and followed up on my case from the beginning. It is a company that I recommend to all my friends. Friends Parker Waichman
Nestor Herrera
5 years ago
5 Star Reviews 150
I worked with Shelly Davis for the past few years regarding my Dad’s 911 claim. My Dad passed away from being at ground zero on 911 due to cancer he developed while working in construction there. Shelly provided the quickest and most efficient information while working with me on this claim. She was quick to get back to me and was always there when I had questions. She was courteous and professional, I highly recommend using Shelly Davis from Parker Waichman.
Lauren Bertman
2 months ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038