Skip to comments.Masters Pharmaceutical Responds To FDA On Ohio Drug Seizures
Posted on 05/25/2014 7:19:26 PM PDT by mgist
Masters Pharmaceutical Responds To FDA On Ohio Drug Seizures
By Cyndi Root
Masters Pharmaceutical issued a press release disputing the Food and Drug Administrations (FDA) position on the raid at Masters subsidiary RXTPL. The FDA and U.S. Marshalls went to RXTPLs logistics facility in Fairfield, Ohio on Thursday, May 15, 2014. The government had a search warrant based on a November 2013 inspection at Ascend Laboratories, which showed the use of unapproved drugs. Masters says that RXTPL cooperated with the government in quarantining the drugs at the facility. However, Masters takes issue with the FDA press release that states that Masters was the distributor of the drugs because it suggests that Masters is the owner of the drugs.
In its original release, the FDA said, U.S. Marshals, at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Ohio, have seized more than $11,185,000 worth of unapproved drugs marketed by Ascend Laboratories of Montvale, N.J. and held by Masters Pharmaceuticals, Inc. of Cincinnati, Ohio.
Dennis Smith, CEO of Masters, said, We have never and would never knowingly sell unsafe drugs to any customer. The products involved here are not owned or sold by RXTPL.
Masters response calls the FDAs news release inaccurate, significantly misleading, unfair, and incorrect. Masters denies that it owns, manufactures, or markets the unapproved drugs. The RXTPL division is a third-party logistics provider for companies without warehousing and distribution facilities. Masters states that RXTPL is just one of many logistics providers across the country. Specifically, Ascend Laboratories rents warehouse space and contracts for staffing, shipping, and other services from RXTPL. Neither Masters nor RXTPL own or market any products at the Ohio facility.
Agreed. It seems millions of dollars worth of pharmaceutical drugs have been seized from a large pharmaceutical co. They say the drugs are illegal. I always port interesting articles like these because you won’t find them anywhere else.
This should have been national news, and the fact that is wasn’t stinks.
It appear there are numerous “pharmaceutical” companies in the US, manufacturing generic Narcotics.
I research links back to creeps like Soros to see what happens and it seems that in addition to us inning the US military to support heroin cartels such as The Muslim Brotherhood, and distributors such as Sinaloa, the FDA is,supporting rogue pharmaceutical companies that are dealing Rx drugs.
Example this company that makes generic OxyContin, who Soros happened to invest in before his Boy, got into the White House.
“George Soros purchased 17531 shares of Mylan Laboratories Inc. between December 31, 2007 and March 31, 2008.”
The FDA is obviously as ridiculously corrupt as the SEC, the only difference being our children rely on the doctors that rely on that agency. Take care of your families.
Sorry for the typos, I’m on a mini iPad and my eyesight isn’t what it was. :)
380 Centennial Avenue Centennial Park , Elstree , , WD6 3TJ , United Kingdom
Phone: 44 2083 270 900
Industry: Wholesale Drugs & Pharmacy Supplies
SIC: Wholesale-Misc Durable Goods (5090)
NAICS: Industrial Supplies Merchant Wholesalers (423840)
Contacts - VIEW DETAILS
Chief Executive Officer
Dave Moran, CEO
Lynda Foster, CEO
Bill Burns, Chairman
Suzad Masters, Director
Shilpa Gohil, Head of Regulatory Affairs
David Hammond, Pharmaceutical Manager
Daniela Carraro, Regional Sales Manager, Latin America
Roger Schmid, General Manager, Asia
Guisela Fabian, General Manager, Central America
Andrew Elder, Non-executive Board Director
30 million in revenue and they just lost a third of that in product. Bankruptcy is ahead and probably the goal.
I was thinking $30 Million in revenue and 70 employees. Something is right here.
Masters Pharmaceutical, Inc., doing business as DBS Trading, Inc., operates as a wholesale distributor of pharmaceutical and medical products for pharmacies in the United States. The company was formerly known as DBS Trading, Inc. and changed its name to Masters Pharmaceutical, Inc. in May 2006. Masters Pharmaceutical, Inc. was founded in 2000 and is based in Cincinnati, Ohio.
11930 Kemper Springs Drive
Cincinnati, OH 45240
Founded in 2000
Apparently it is very easy to open a “pharmaceutical company”.
Dbs Trading Inc
A privately held company in Loveland, OH.
More Details for Dbs Trading Inc
Categorized under Nondurable Goods, Nec. Our records show it was established in 2007 and incorporated in Ohio. Current estimates show this company has an annual revenue of less than $500,000 and employs a staff of approximately 1 to 4.
Or it could be a case of an abusive government taking out competition, extortion, or ineptness.
U.S. Marshals and the FDA have seized $11 million in drugs that sit in Norwood-based Masters Pharmaceuticals’ warehouse. The company says it is not at fault.
Cincinnati Business Courier
The general counsel for Masters Pharmaceutical had sharp criticism for the Food and Drug Administration today after the agency announced it quarantined millions in drugs from its Fairfield warehouse.
Rick Lauer, general counsel and vice president of strategy acquisitions, called the statement issued by the FDA”unfortunate and misleading.”
“The product seized by the FDA does not belong to Masters,” he said. “We are a third-party logistics provider.”
The products belong to Ascend Laboratories of Montvale, N.J., which rents warehouse space from Masters. The drugs include Pramoxine-HC Otic Drops, intended to treat infections of the external ear; Hydrocortisone Acetate Suppositories 25 mg, intended to treat inflammatory conditions; and Urea Cream 39%, Urea Cream 40% and Urea Lotion 40%, intended to treat conditions such as dermatitis and eczema.
A representative from Ascend Laboratories could not be reached for comment.
“We are being treated worse than the actual liable party here. It is the manufacturer who is ultimately responsible that they are manufucturing an approved product,” Lauer said.
FDA spokesman Christopher Kelly refused to discuss the agency’s statement.
We stand by the press release,” he said. “We dont have anything further to comment on.”
Lauer said the company has been flooded with calls from its bankers and customers after news organizations picked up the press release from the FDA, which prominently names Masters as involved in the seizure.
“We are not a target of the investigation,” said Lauer. “We are not responsible for making sure (these kinds of drugs) in our warehouse are approved.”
Lauer stressed that there is no financial impact to Masters as a result of the raid. The company is operating as normally, and the product in question has been quarantined.
“Our only issue with the FDA is that their press release was misleading. It implies the product is owned by us and was seized from us. That is not accurate. It is owned by Ascend and was seized from Ascend,” he said.
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The drugs include Pramoxine-HC Otic Drops, intended to treat infections of the external ear; Hydrocortisone Acetate Suppositories 25 mg, intended to treat inflammatory conditions; and Urea Cream 39%, Urea Cream 40% and Urea Lotion 40%, intended to treat conditions such as dermatitis and eczema.
Just what is wrong with these medications? Why are they unapproved? Creams containing urea have been used for a long time for dry skin, for example.