Caraco to Eliminate Nearly 350 Employees Due to FDA Seizures

Caraco Pharmaceutical Laboratories has announced that it will eliminate approximately half of its employees and curb overhead by suspending all manufacturing following the seizure by the US Food and Drug Administration (FDA) of up to 33 of the company's generic drugs due to manufacturing violations. This is anticipated to impact over 350 employees.

In June 2009 the FDA seized drugs made at the company's Michigan facilities in Detroit, Farmington Hills and Wixom. The seized drugs included generic versions of heart, pain and psychiatric drugs as well as the epilepsy treatment Tegretol and a generic copy of the diabetes drug Glucophage.

Earlier in 2009 Caraco had been charged with repeated violations of FDA’s current Good Manufacturing Practice (cGMP) requirements. Beginning in January 2009, Caraco initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

XStream Systems endorses the concept of material screening of pharmaceuticals from raw materials, through the various points of production, within the distribution supply chain and at the point of dispense.

Validation at all points of the pharmaceutical supply chain from the manufacturer to the consumer verifies quality and protects against counterfeiting, fraud and adulteration.

U.S. Marshal Seizes Drugs Manufactured by Caraco Pharmaceutical Laboratories

FDA acts to prevent repeated drug quality problems

Yesterday, U.S. Marshals, at the request of the Food and Drug Administration, seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities.

This action follows repeated violations of FDA’s current Good Manufacturing Practice (cGMP) requirements. Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

The FDA’s most recent inspection of Caraco, completed in May 2009, found unresolved violations of cGMP requirements. FDA’s seizure is intended to lead to major changes at Caraco’s facilities.

The FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, choline magnesium trisalicylate oral tablets, which are commonly used as pain relievers.

"The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements," said Michael Chappell, FDA acting associate commissioner for regulatory affairs.

Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMPs. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.

To View the entire FDA press release visit: www.fda.gov.
To view the listing of products affected by this recall visit: www.fda.gov.

Are Counterfeit Drugs in the U.S. Supply Chain?

The general consensus has always been that only a small amount of counterfeit drugs are in the domestic supply chain. True relatively speaking, the percentage of counterfeits found in the United States is lower (estimated at around 1%) than some underdeveloped countries (estimated as high as 50%).

However, this does not paint the whole picture… The U.S. has almost 43% of the market share, which means there are still thousands of counterfeit pills in our distribution cycle. To the consumer that is a victim, it matters not whether he is in the company of many fellow victims or only a few.

Furthermore, the frequency of counterfeits is increasing in more developed countries such as the U.K and the U.S. Now, incidents are showing up in the regular supply chain as you can see from the following news items:

First Foreign National Extradicted For Importing And Distributing Counterfeit Pharmaceuticals Drugs In U. S. Sentenced To Prison
Randy Gonzales, 40, a citizen of the Republic of the Philippines, was sentenced to prison for his role in a scheme to manufacture, import and distribute counterfeit pharmaceutical drugs in the United States.

Gonzales was extradited to the United States from Bangkok, Thailand on March 26, 2008 and indicted four days later. Special agents of the Immigration and Customs Enforcement (ICE) and the Food and Drug Administration Office of Criminal Investigations (FDA)seized more than 60,000 counterfeit Viagra pills and 15,000 counterfeit Cialis pills. The counterfeit drugs were valued at more than $776,000.


Miami Man Sentenced To 20 Years For Massive Drug Diversion Operation
A Miami man has been sentenced to 20 years in prison for running a massive drug diversion operation that made millions of dollars in illegal profit. Jose Luis Perez, 52, had illegally bought expired, counterfeit or adulterated medicines, relabeled them and shipped them through a series of his own pharmaceutical firms in order to sell them to mainstream suppliers.

Investigators were tipped off by a Cincinnati pharmaceutical wholesaler who, while filling a prescription, noticed that the wrong pills were inside and the accompanying paperwork was for a different drug.

At Perez’ Hialeah warehouse, law enforcement officers found $500,000 of prescription pills used for the treatment of HIV-related illnesses, Schizophrenia and erectile dysfunction. Law enforcement also found counterfeit labels and prescription paperwork for more that $8 million-worth of pharmaceuticals.


Local pharmacist, businesses disciplined by state
(Nov. 30, 2008; The Telegraph) In 2006, Hudson resident Richard Minasian, owner of Nashua-based Armin Medical LLC, pleaded no contest in a Florida court that he and a Miami man had sold drugs with fake pedigrees.

That same year, the New Hampshire Board of Pharmacy revoked Minasian's license to sell drugs for at least 10 years, and he was assessed a $29,000 fine, but $20,000 of it was stayed for two years pending good behavior.


As these stories indicate, government intervention is gearing up and we at XStream Systems applaud the increased authority given to FDA and law officials to seize products and prosecute criminals. But the reality is that these undercover operations often take a year or more to complete. During this time consumers, wholesalers, and repackagers are exposed.

Now is time for businesses to protect themselves and their customers by effectively securing their on-site inventories. It is too late to hide our heads in the sand and deny that counterfeits exist – they do and what are the implications for you if they unknowingly pass through your hands!

Diethylene glycol, killer on the prowl

Nigerian death toll rises in tainted infant teething drug

The latest victims to greed are the smallest among us…….

Over 45 babies have died in Nigeria from the tainted teething syrup, "My Pikin Baby Teething Mixture". The medicine is contaminated with diethylene glycol, causing kidney failure in the children who died.

The National Agency for Food, Drug Administration and Control (NAFDAC) has shut down the manufacturer of "My Pikin", Lagos-based Barewa Pharmaceuticals, as well as a company called Tranxell Ltd, which is believed to have supplied chemicals to Barewa and possibly to other local drugs manufacturers.

Diethylene-glycol-contaminated products have had a long history in dealing death. This chemical, which is used in antifreeze, is sometimes added illegally as a cheaper sweetener or thickening agent with deadly results.
So deadly in fact, that the catastrophic deaths following its first use in medicines led to the passage of the 1938 Federal Food, Drug, and Cosmetic Act.

In 1937 more than 100 U.S. citizens, many of them children, died when diethylene-glycol was added to an antibiotic to make the liquid form, Elixir Sulfanilamide.

And their deaths were painful as noted in a grieving mother’s letter to President Franklin D. Roosevelt:

"The first time I ever had occasion to call in a doctor for [Joan] and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. ... It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight."

According to the World-wide Organization of the Health during the 1980's and 1990's more than 600 people were killed by this type of contamination.

Furthermore it continues still today and is becoming more prevalent. In 2007, Diethylene glycol was found in contaminated toothpaste manufactured in China. Over a hundred people died in Panama. That same year The New York Times reported that about 900,000 tubes turned up in the United States, including correctional facilities, juvenile detention centers, and some hospitals, as well as discount stores.

In today’s global economy ingredients can be manufactured anywhere and consumers rely on companies to look out for their safety. Authentication of raw materials is essential to ensure the safety of consumers and mitigate the risks of contamination to the finished product.

Government Seizes Contaminated Heparin STILL in the US Supply Chain?

In a news report, the Federal Agents seized contaminated Heparin a full seven months following the recall. Read the full story.

It seems shocking that after confirmed deaths of over 250 people that this type of product would still be in the domestic supply chain. “I think that this is an illustration of how many gaps that remain in the process and the system that leaves the US consumer at risk,” stated Alan Clock, SVP of XStream Systems. “Those within the supply chain that believe that they are not vulnerable or that the burden of product safety lay elsewhere are in for a rude awakening when not if the next counterfeit or adulterated products hit their warehouse or store shelves.”

To learn more about XStream Systems revolutionary materials analysis solution to counterfeit, contaminated or adulterated products please visit us at www.xstreamsystems.net.