Can You Believe It? J&J Announces Another Recall...

McNeil Consumer Healthcare Initiates Yet Another Voluntary Recall Of Certain Products.

Just when you thought it could not get much worse for J &J, on Friday Johnson & Johnson’s McNeil Consumer Healthcare Division, in consultation with the U.S. Food and Drug Administration recalled certain lots of TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® products distributed in the United States, the Caribbean, and Brazil.

The J &J company statement said that the recalled products were manufactured at the McNeil plant in Fort Washington, Pennsylvania prior to April 2010, when production at the facility was suspended. The company is initiating the recall as a precautionary measure after an extensive review of past production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented. It is very unlikely that this impacted the quality of these products.

In addition, McNeil Consumer Healthcare is also initiating a voluntary recall of certain product lots of ROLAIDS® Multi-Symptom Berry Tablets distributed in the United States, in order to update the labeling. The company initiated the recall after determining that the product labeling does not include the language “Does not meet USP” as required by regulation.

According to the press release, McNeil identified the inadequacies as part of a thorough, proactive product quality and process assessment of all McNeil produced products.

On all levels this is a saga of an industry giant that has poorly managed the entire process of production, product quality control, regulatory affairs and public relations. J&J’s entire corporate image, trusted brands, executive management and financial future is in a significant state of decline.

J&J’s announcement of a comprehensive plan to clean up its production and public image is a operational and PR process that should have been initiated many months ago.

The lost sales, enormous expense in recalls and cost to the brands has to be a huge hit to J&J's bottom line.

This story is a cautionary tale for all, not making an investment in and failure to take the necessary steps to assure quality control and to protect your brand from sub-standard production, poor quality raw materials, fraud, adulteration and counterfeit will cost the stakeholders and consumer.

What are the odds that we will see another recall from J&J soon?

To learn more about supply chain authentication technologies, visit: http://www.xstreamsystems.net/

Pharmalot: The Sorry List of Johnson & Johnson Troubles

“We now see a strong likelihood of near-term FDA enforcement action.”

Once again Ed Silverman in his Pharmalot blog outlines the issues that have plagued the pharmaceutical industry giant over mandated recalls, “phantom recalls”, other regulatory misdeeds that have impacted their venerable brands including Tylenol, Mylanta, Motrin, Rolaids and Benadryl.

In his blog, Mr. Silverman cites Wells Fargo Securities analyst Larry Bigelsen regarding the potential impact of continued FDA scrutiny on their operations and to J&J stock.

This blog presents some interesting, whimsical insight into the depth of the problem and the potential impact operationally and financially to J&J.

Secure Pharma Chain sees this as a cautionary tale to the pharmaceutical supply chain- protect the production, quality, efficacy and distribution of your product and inventories within the supply chain or risk the reputation and viability with the consumer. The stakes are high and the consequences to the brand and the consumer can be lethal.

It is vital that all members of the pharmaceutical supply chain deploy and utilize technologies that protect consumers from adulterated, fraudulent, sub-standard, poor quality and counterfeit drugs.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/12/the-sorry-list-of-johnson-johnson-troubles/

To learn more about pharmaceutical authentication technology, visit: http://www.xstreamsystems.net/.

Pharmalot: Killing Snakes with Bad Tylenol

Pharmalot has a great suggestion for the J&J CEO to turn the recent recalls into a win-win.

Ed Silverman in his September 8th blog titled, Snake in the Grass, J&J Can Recoup Tylenol Losses, has come up with a novel way to turn this bad situation by donating the recalled Tylenol to the U.S. military for “a perfectly good cause”.

Apparently the U.S. military has come up with a solution for their invasive brown tree snake problem at their naval base in Guam. They have discovered that snakes die when they consume acetaminophen. They now are proposing dropping mice fed with acetaminophen from a helicopter into the jungles surrounding the base…

As Mr. Silverman so eloquently elaborates:

Snakes, after all, do not care if their Tylenol smells musty or contains metallic flecks. Grind ‘em up, feed ‘em to the mice, drop the mice in the jungle and, voila, no snakes. And for Weldon, no embarrassing trips to the landfill.

“The discovery that snakes will die when they eat acetaminophen was a huge step forward,” Anne Brooke, conservation resources program manager for Naval Facilities Command Marianas, tells Stars and Stripes “The problem was how you get the snakes to eat it.”

Putting Guam aside for a moment, this could be the public relations coup that Weldon so desperately needs. Rather than sheepishly dispose of millions of Tylenol tabs in the middle of the night, he and his new quality control team can be photographed proudly donating the poorly made goods to an effort that serves vital US interests. And best of all - J&J may be able to realize a tax break in the process. How’s that for leadership possibilities?

I guess if you are the CEO of J&J you have to take the lampooning when under your watch, your company so thoroughly botches quality control and the subsequent attempt to cover its tracks from the consumer and the government.

Clearly the entire situation is a cautionary tale for the entire supply chain. Thankfully for all, the only fatalities to this recall, other than some careers and stock portfolios, will be to the population of the brown tree snake in Guam.

To read the Pharmalot post, visit: http://www.pharmalot.com/2010/09/snake-in-the-grass-jj-can-recoup-tylenol-losses/

To learn more about supply chain authentication solutions, visit: www.xstreamsystems.net.

Pharmalot: J&J Fires 300 Employees Over the Tylenol Recalls

Once again Ed Silverman in his Pharmalot blog continues to maintain the best insight and commentary on the never ending J&J Recall scandal.

In a July 15th blog, Mr. Silverman reports on J&J’s recent publicly released statement which included the announcement that they will fire 300 to 400 people who work in the Fort Washington, Pennsylvania McNeil plant. This is the site and headquarters where most of the quality-control problems were found and the managerial decisions were made.

Mr. Silverman’s Pharmalot commentary included:

· The healthcare giant submitted its long-awaited remediation plan to the FDA today - you know, the plan that is supposed to help Johnson & Johnson’s McNeil Consumer Healthcare unit get back on track after recalling tens of millions of over-the-counter pediatric medicines. And in a vague statement, J&J says one way to cope is to can 300 of the 400-plus people who work at the Fort Washington, Pa., plant where most of the quality-control problems were found and managerial decisions were made.

· The employees are being let go because it’s not clear when the plant will operate again. A J&J spokeswoman says the “best estimate” is the middle of 2011. Recently, J&J acknowledged that a few hundred million dollars in sales will be lost; the average annual sales of the products made at this plant over the last three years were about $650 million, although that remains a sliver of J&J consumer sales, which last year were $4.2 billion out of $16.5 billion total sales worldwide. J&J vows to expand capacity elsewhere to compensate for the shortages.

· There was no word, however, whether any senior McNeil execs are among those being shown the door, given that the McNeil unit is headquartered in Fort Washington. Take Peter Luther, who heads the unit. He allegedly recommended a recall of Motrin pills without notifying the FDA or the public.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/07/jj-fires-300-employees-over-the-tylenol-recalls/#more-24878.

As quality control issues continue to dog large branded and generic pharmaceutical companies it is vital that all members of the pharmaceutical supply chain monitor the quality and protect their inventories in order to make certain that health care consumers have access to safe and efficacious medications.

Secure Pharma Chain Blog endorses material authentication which can be deployed easily and efficiently within the supply chain to verify the authenticity and quality of medications within their unit of sale container.

To learn about material authentication solutions, visit: http://www.xstreamsystems.net/.

Johnson & Johnson, The Recalls Continue

J&J recalls more Tylenol, over-the-counter drugs, recalled lots linked to odors.

Johnson & Johnson recalled more Tylenol and other over-the-counter drugs on July 8th after the 21 lots of Tylenol, Benadryl and Motrin were linked to a musty or moldy odor. This action continues to expand a recall the company’s McNeil Consumer Healthcare unit started in January.

Johnson & Johnson’s McNeil Consumer Healthcare unit said the latest recall involved 21 lots of medications, including Tylenol for children and adults, several forms of Benadryl allergy tablets and Motrin painkiller. However J&J spokesperson Bonnie Jacobs was unable to disclose how many pieces were in each lot or give a total number of items involved.

Thursday's recall, like the one in June, was related to J&J's January recall of 53 million bottles of widely used products, which were also linked to odors.

On June 15, J&J recalled four lots of Benadryl and one lot of Extra Strength Tylenol gels.

"These lots are being added to the list of recalled products as a precautionary measure after a continuing internal review determined that some packaging materials used in the lots had been shipped and stored on the same type of wooden pallet that was tied to the presence of TBA in earlier recalled lots," Johnson & Johnson said in a press statement.

As with the previous recalls, Johnson & Johnson are encouraging consumers who have purchased the products included in the recall should stop taking them and contact the company about a refund or replacement

Not counting the subsequent follow up recalls to the January 15th recall, McNeil has issued four product recalls in the past year due to quality control problems at its plants, sparking a congressional investigation and scrutiny from the U.S. Food and Drug Administration.

Secure Pharma Chain Blog encourages all within the pharmaceutical supply chain to authenticate and verify the quality of their inventories while protecting consumers from fraud, adulteration and counterfeit product.

To learn more about pharmaceutical supply chain solutions to quality control and product authentication, visit: http://www.xstreamsystems.net/.

J&J Unit Recalls More OTC Drugs

Late Tuesday, Johnson & Johnson's McNeil Consumer Products division announced the inclusion of several other of its hugely popular brands to its massive OTC recall. It is now recall four lots of Benadryl allergy tablets and one specific lot of its Extra Strength Tylenol gel pills.

Including this recent recall announcement Johnson & Johnson’s McNeil Consumer Products division has issued four recalls over the past twelve months.

Various media outlets are reporting on this development:

The New York Times: "The Johnson & Johnson unit whose recall of liquid children's Tylenol and other pediatric medicines is under Congressional investigation said on Tuesday evening that it was recalling additional over-the-counter drugs." Specifically, McNeil Consumer Healthcare "said that it was recalling four lots of certain Benadryl allergy tablets and one lot of Extra Strength Tylenol gel pills." According to a company statement, "'the products were inadvertently omitted' from an earlier recall -- one preceding the children's drug recall -- involving medicines made at a company plant in Puerto Rico." Although the drugmaker maintains that the chances of experiencing serious side effects are nil, it began recalling products from the Las Piedras plant in November after consumers were reportedly overcome by a mildew-like odor.

The Wall Street Journal: The smell purportedly prompted stomach pain, diarrhea, and nausea. The unit has since identified the manufacturing issue.

Bloomberg News: "the odor has been linked to trace amounts of a chemical called 2,4,6-tribromoanisole, or TBA, found on storage pallets."

Reuters: US House of Representatives Oversight and Government Reform Committee Chairman Edolphus Towns (D-NY) said, "This latest recall is further evidence that there are wide-ranging problems at Johnson & Johnson." He added, "I am troubled by what we have learned so far in our investigation, and this latest development adds to my concern."

The recent proliferation of recalls generated from pharma manufacturers due to poor quality production, inadequate quality control, cargo theft and various other adulterations to the consumer product strengthens the concept of material authentication by all members of the pharmaceutical supply chain. Material authentication, inside the products unit-of-sale container protects the members of the suppy chains inventories and the end use consumer.

To read the various reports on this recent announcement and the J&J recall from The New York Times, Wall Street Journal, Bloomberg News and Reuters, visit these sites:

http://www.nytimes.com/2010/06/16/health/16drug.html.

http://online.wsj.com/article/SB10001424052748704009804575309132577939048.html?mod=googlenews_wsj.

http://www.bloomberg.com/apps/news?pid=20601202&sid=awltXaS.MHl4.

http://www.reuters.com/article/idUSN159754220100615.

To learn more about pharmaceutical supply chain security solutions that protect the supply chain and consumers from poor quality, fraudulent, adulterated and counterfeit drugs, visit: http://www.xstreamsystems.net/.

Phamalot: Johnson & Johnson And Its Mystery Shoppers

Pharmalot, Ed Silverman’s excellent pharmaceutical insider blog posted a riveting blog on the continued saga of the truth behind Johnson & Johnson's recent recalls of its hugely popular over-the-counter brands which included Motrin and Tylenol.

Currently the industry giant finds itself in embroiled in Congressional investigations and regulatory review from the FDA which may involve criminal charges.

Here are some of the highlights from the Pharmalot blog:

· The Johnson & Johnson recall scandal is threatening to envelope the healthcare giant in ways that, just a few months ago, no one could imagine. The latest twist involves a series of emails that appear to lend further credence to what a Congressional committee is calling a ‘phantom recall,’ which was allegedly undertaken to obscure serious problems with widely used over-the-counter pediatric medications. The episode is part of a long-running chain of events may prompt the FDA to consider criminal charges.

· At issue are quality-control failures that forced J&J to recently recall tens of millions of bottles of such venerable brands as Tylenol and Motrin, among others, which had been found to contain too much active ingredient or metallic specks. But instead of issuing a recall, J&J hired an outside contractor to buy Motrin from stores, and its employees were instructed to act like “regular customers” and not discuss a possible recall. This was disclosed at a May 27 Congressional hearing.

· Since then, internal J&J documents obtained by Pharmalot would appear to undercut some of J&J’s contentions, such as the notion that its contractor’s assignment was limited and transparent. A J&J spokeswoman told The New York Times the contractor’s memo was created without the knowledge of its McNeil Consumer Healthcare unit. But e-mails suggest J&J employees were aware, including Lily Vandermolen, an associate product director at McNeil, and Carolyn Parziale, a diretor of quality assurance at McNeil.

Mr. Silverman’s blog goes into detail about Johnson & Johnson’s insider knowledge and it would surely mean that there are many documents that leave a trail to an institutional knowledge of the product out in the supply chain was well known to have quality issues and be potentially harmful to the consumer.

Secure Pharma Chain Blog endorses that all members of the pharmaceutical supply chain deploy technologies and solutions to actively verify the authenticity and quality of its inventories to protect themselves and the consumers from poor quality control, adulteration, fraud and counterfeit product.

To learn more about authentication technologies that can verify pharmaceutical products inside their sealed unit-of-sale container, visit: http://www.xstreamsystems.net/.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/06/johnson-johnson-and-its-mystery-shoppers/#more-23843.

CNNMoney.com: Serious Side Effects of Tylenol Recall Investigated

CNNMoney.com Senior Writer Parija Kavilanz reported on May 25th on the Food and Drug Administration investigation into reports of at least 775 serious side effects from drugs recalled by McNeil, a division of Johnson & Johnson.

McNeil is also under a Congressional investigation regarding the recall, the House Committee on Oversight and Government Reform has scheduled a hearing on May 27th to examine the recall.

Highlights from the report include:

• Included in the reports were 30 deaths, nearly all of which were found to not be tied to McNeil's recall of Tylenol, Motrin and Benadryl drugs from Jan. 1, 2008 through April 30, 2010, according to another source close to the investigation.

• The FDA is also investigating reports of several hundred serious side effects -- or "adverse events" -- and seven deaths since May 1, when McNeil recalled 50 children's versions of these non-prescription medicines because of serious quality and safety concerns.

• Following the most recent recall, Johnson & Johnson (JNJ, Fortune 500) has suspended production at McNeil's facility in Fort Washington, Penn., that manufactured the children's drugs.

• The FDA, which earlier this month issued a scathing 17-page inspection report listing 20 violations at the Fort Washington plant, also maintains that the recalled drugs pose a "remote" potential for serious health problems.

• McNeil has maintained that its recall of the children's drugs was not "undertaken on the basis of adverse medical events" but as a precautionary measure.

McNeil's latest recall is its fourth in the past seven months:

• In November 2009, five lots of Tylenol Arthritis Pain 100 count with the EZ-open cap were recalled for unusual odor leading to nausea, stomach pain, vomiting and diarrhea.
• In December, the recall was expanded to include all product lots of Tylenol Arthritis Pain caplet 100 count bottles with the red EZ-open cap.
• In January 2010, the recall was widened to an undisclosed number of Tylenol, Motrin and other over-the-counter drugs after complaints of consumers feeling sick from an odor.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing and quality assurance concerns by pharmaceutical companies have been discovered within the supply chain that could and should have been detected at various points of the supply chain by readily available material authentication solutions.

To learn more about supply chain material authentication solutions, visit: http://www.xstreamsystems.net/.

To view the CNNMoney.com story, visit: http://money.cnn.com/2010/05/25/news/companies/tylenol_recall_adverse_consumer_complaints/index.htm.

New York Times: In Recall, a Role Model Stumbles

Natasha Singer writes an excellent article in the January 17th issue of the New York Times regarding the recent management of a sweeping product recall by McNeil Consumer Healthcare, a division of Johnson & Johnson.

In this article, Ms. Singer explores how a company with the reputation of Johnson & Johnson, who is seen as the “gold standard” of crisis management, seemingly botches this most recent issue of product contamination within the supply chain.

Secure Chain Pharma Chain Blog has reported extensively on this particular recall and believes that this incident, which is based on onsite product contamination, energizes the need for material screening of products within the supply chain to protect consumers from fraud, adulteration, contamination and counterfeit products.

The following is an excerpt of the Ms. Singer’s article:

The Harvard Business School teaches future executives the gold standard in brand crisis management. The model dictates that a company should communicate clearly with the public about a crisis, cooperate with government officials, swiftly begin its own investigation of a problem and, if necessary, quickly institute a product recall.

The template is based on Johnson & Johnson’s conduct in 1982, when several people died after taking tainted Tylenol pills. The company’s reaction to the crisis is widely regarded as exemplary.

But last week, Johnson & Johnson appeared to abandon its own template, stunning a few business school professors. Its conduct also drew harsh criticism from federal officials.
On Friday, McNeil Consumer Healthcare, a division of Johnson & Johnson, announced the recall of several hundred batches of popular over-the-counter medicines, including Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol.

According to a federal inspection report, the response was anything but swift. The recall came 20 months after McNeil first began receiving consumer complaints about moldy-smelling bottles of Tylenol Arthritis Relief caplets, according to a warning letter sent by the Food and Drug Administration to the company on Friday. Since then, a few people have also reported temporary digestive problems like nausea, vomiting and stomach pain, the agency said.

To read the entire article, visit:

http://www.nytimes.com/2010/01/18/business/18drug.html?th&emc=th

To learn more about technologies which will protect inventories within the supply chain, visit:

http://www.xstreamsystems.net/.

Johnson & Johnson: Massive Expansion of Recall

As an update to an earlier Secure Pharma Chain Blog report, Johnson & Johnson has massively expanded a recall of their OTC medications. This is the second expansion of a recall due to a moldy smell of these particular products that are making consumers ill.

The recall now includes specific lots of Tylenol caplets, gel tabs, arthritis treatments, rapid release and extend release Tylenol as well as Motrin IB, regular and extra strength Rolaids antacids, Benadryl allergy tablets, St. Joseph aspirin and Simply Sleep caplets.

McNeil Consumer Products, a division of Johnson & Johnson, is publicly stating that the expanded recall includes product lots that could be affected by the same problems of consumers experiencing nausea and vomiting that were the reason for the original recall, even though it has not received any reports from consumers.

The latest update recall applies to Johnson & Johnson/McNeil products sold in the North America, Central and South America, the UAE and Fiji.

A full list of the recalled products is online at http://www.mcneilproductrecall.com/.

Previously Johnson & Johnson recalled some Tylenol Arthritis Caplets in November and December due to the moldy smell, which caused nausea, stomach pain, vomiting and diarrhea to some consumers.

Johnson & Johnson says the smell is caused by small amounts of a chemical associated with the treatment of wooden pallets.

This recall, based on onsite product contamination, energizes the need for material screening of products within the supply chain to protect consumers from fraud, adulteration, contamination and counterfeit products.

To learn more about onsite pharmaceutical material screening solutions, visit: www.xstreamsystems.net.

ABC News: FDA Looking into Tylenol Arthritis Pain Caplets Recall

ABC World News is reporting that the US Food and Drug Administration is investigating the process of the recall and the way that it has been communicated to consumers.

November, Tylenol posted a small recall on its website. Twelve days ago, all six million bottles were recalled. However, it wasn't until a nationwide FDA medical alert just this Monday that most people learned the bottles had been recalled.

In an analysis piece aired on ABC World News, ABC’s Senior Medical Editor Richard Besser, MD, advised consumers what actions to take if they have the recalled Tylenol. Dr. Besser explained that consumers who have the Tylenol arthritis caplets in the Easy Cap bottles should get rid of them by safely disposing them in their trash.

On Wednesday, the deputy commissioner of the FDA, Joshua M. Sharfstein, MD, said the agency is "looking into...the case," additional stating "a system that relies on the consumer to either visit websites or to sign up for multiple web blogs or email alerts, I don't think is the way we want to alert consumers about recalls."

Tylenol Pain Caplets Recalled Due to Trace Chemical Which Causes Nausea and Vomiting

The Associated Press and other major media outlets are reporting that Johnson & Johnson is expanding a voluntary recall of Tylenol Arthritis Caplets due to consumer reports of a moldy smell that can cause nausea and sickness.

The FDA released a statement on their website that Johnson & Johnson is now recalling all product lots of the Arthritis Pain Caplet 100 count bottles with the red EZ-Open Cap. Johnson & Johnson had previously recalled five lots of the product last month after consumers complained of a musty, mildew-like odor that triggered nausea, stomach pan, vomiting and diarrhea.

Johnson & Johnson is saying that the odor results from trace amounts of a chemical called 2, 4, 6-tribromoanisole. That chemical is believed to result from the breakdown of another chemical used to treat wooden pallets that transport and store packaging materials. To date, the side effects, which also include vomiting and diarrhea, have been "temporary and non-serious," although the health effects of the compound have not been studied.

The company will reintroduce Tylenol Arthritis Pain Caplets 100 count by January after moving production to a new facility.

For more information on the recall visit the Tylenol website: http://www.tylenol.com/.

This recall, based on onsite product contamination, energizes the need for material screening of products within the supply chain to protect consumers from fraud, adulteration, contamination and counterfeit products.

To learn more about onsite pharmaceutical material screening solutions, visit: www.xstreamsystems.net.

“Buyer Beware” List of Products for Shoppers to Steer Clear on Auction Sites

The National Retail Federation (NRF) has updated their list of products most susceptible to retail theft. Some of these household items are being sold on online auction site. The danger for these products is the consumer has no idea in what conditions the items were stored and when the items are medicinal in nature this poses a health risk to the buyer.

“Though retailers suffer billions of dollars in losses each year from organized retail crime, they are not the only group who’s hurt,” said Joe LaRocca, NRF senior asset protection advisor. “Most stolen merchandise is not stored properly and could expose unsuspecting shoppers or their children to a host of risks from spoiled baby formula and pain medication to inaccurate results from diabetic test strips or pregnancy tests.”


Medicinal products listed included:

• Abreva
• Advil
• Aleve
• Alli weight loss pill
• Claritin
• diabetic testing strips
• e.p.t. pregnancy tests
• Pepcid AC
• Prilosec
• Sudafed
• Tylenol Extra Strength
• Visine
• Zantac

For information about the dangers of using expired or improperly stored medication, visit the U.S. Food and Drug Administration.

To view the entire list of household products visit: www.nrf.com

Cargo of Tylenol Stolen in Jacksonville Florida

Cargo thefts seem to be on the rise… The latest alert comes via FDA press release this week:

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is working with the U.S. Food and Drug Administration, Office of Criminal Investigations (FDA), and other law enforcement officials to recover cases of select lots of TYLENOL® Arthritis and TYLENOL® PM products that were stolen from a cargo terminal at the Jacksonville Port Authority in Jacksonville, Florida on September 25, 2009.

The products stolen were cases of:

• TYLENOL® Arthritis Pain Caplet 150 count bottles (57,456 bottles) Lot 09XMC112


• TYLENOL® PM Caplet 2 count packets (180,000 2 caplet pouches) Lot 09XMC110

Consumers who received or purchased either of these products should check to see if they are from the stolen lots (lot numbers listed above).

McNeil Consumer Healthcare and the FDA are asking for the public's help in reporting any information regarding the stolen TYLENOL® products to FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

To view the entire announcement visit: http://www.fda.gov/ICECI/CriminalInvestigations/ucm186269.htm.