FDA ORDERS PROPOXYPHENE, Dextropropoxyphene, Darvocet and others off Drug Store Shelves

SOURCE - Consumer Acumen

The FDA has asked that Dextropropoxyphene aka Propoxyphene - Trade-names for Propoxyphene include Darvocet-N and Di-Gesic Darvon with APAP for dextropropoxyphene and paracetamol and Darvon with ASA for dextropropoxyphene and asperin. According to the FDA Report, Propoxyphene "puts patients at risk of potentially serious or even fatal heart rhythms” and concluded its risks outweigh the benefits of using Propoxyphene for pain relief. Darvon is propoxyphene alone, and Darvocet combines that ingredient with acetaminophen (aka Tylenol)

Other brand names of Propoxyphene included in the recall are Darvon and Darvocet, Xanodyne Pharmaceuticals be removed from the US market. The Propoxyphene recall will also effect generic Propoxyphne manufacturers and the manufactorers of propoxyphene-containing products. The maker of the branded version of the drugs, Xanodyne, has already said it will comply with the Propoxyphene recall notice.

The FDA has told medical professionals to stop prescribing propoxyphene. Patients who are taking the stated medications should not sinply stop taking it, ut should contact their doctor soon as possible to discuss switching to another pain-management therapy. The WSJ reports that in 2007, there were 20 million prescriptions written for the two drugs.


Propoxyphene is an opioid typically used to treat mild to moderate pain. It was first approved by the FDA in 1957. It is sold by prescription under various names alone or in combination with acetaminophen. Since 1978, the FDA has received two requests to remove propoxyphene from the market.


Darvon has been controversial for years. Public Citizen started asking for its removal way back in 1978 and today said the FDA’s move came too late to save many lives. It called propoxyphene a “deadly but barely effective painkiller.” (Though the Health Blog has been prescribed Darvocet before and it certainly left us feeling no pain.)

In 2005, the UK ordered propoxyphene off the market on concerns that it was too easy to overdose on the drug. Europe’s main medical regulator recommended its removal in 2009.

About a month after the European decision, the FDA said it would require a boxed warning on Darvon and Darvocet. It ignored the advice of an outside advisory panel to pull the drugs entirely, saying they were an “acceptable” option when used at recommended doses. It said it required Xanodyne to conduct a new safety study and that those results are what led to today’s action.

In January 2009, an FDA advisory committee voted 14 to 12 against the continued marketing of propoxyphene products. At that time, the committee called for additional information about the drug's cardiac effects.


For those patients being removed from Propoxyphene, you should be aware of the possible side effects of Opioid Withdrawl. In pure form, dextropropoxyphene is commonly used to ease the withdrawal symptoms in people addicted to opioids. Being very weak in comparison to the opioids that are commonly abused, dextropropoxyphene can only act as a "partial" substitute. It does not have much effect on mental cravings; however it can be effective in alleviating physical withdrawal effects, such as muscle cramps.

Some previously reported side effects of Propoxyphene include Urinary Hesitancy, Itching, Drowsiness, Sore Throat, Impaired Alertness, Confusion, and Serious or Fatal Heart Rhythms.

Pro Activ Pro-Activ a Proactive Approach to Marketing.

It seems the new marketing buzzword of the decade is "Pro-Activ" or various forms of it such as "Pro Activ" etc. So what does Pro Activ mean? Well, in a nutshell, without the "e" at the end, absolutely nothing.

Your Ad Here

It first started with Yogurt companies vying for the weight loss market by taking the Active part of the central part of all yogurt "Active Bacteria" and combining it with the other part "Probiotics" and they created their own word "Pro Activ" Of course, this bears a striking resemblance to the word Proactive which implies taking control. So the thought process must be, by taking ProActiv, you are taking a Proactive approach to your health. Brilliant.
Of course there are many manufacturers of Yogurt and everyone started using the term Probiotic to describe their yogurt. Simply look at the yogurt labels next time you are at the grocery store and you will see what I mean. All these names and numbers leave one wondering what is the best Probiotic. Well, there is no simple answer to what the best probiotic yogurt or the best probiotic supplement is. Fact of the matter, all yogurts consist of Proactive bacterial cultures and one would assume each one acts differently. The most known of these active bacterial cultures is acidophilus bifidium.
Personally, I have gone the route of buying several versions of unflavored probiotic yogurt and created my own "super probiotic yogurt" Of course, this would not work on a commercial level because some of these probiotic cultures are protected by patents and would potentially result in a lawsuit. Kinda funny, actually.
Probiotics have also hit the suplement market. There are several versions of vitamins or supliments on the market with various active bacteria in them. The most recent to hit the search engines is Align Probiotics. This has people searching for side effects of Align Probiotics Align Side Effects Probiotic Side Effects, Align Probiotics reviews and of course, the Best Probiotics. Apparently, there is some sort of Align Probiotic coupon you can print out there.
Not to be outdone, the next level of marketers decided to take Proactiv to a whole new level, the Skin. There is now a Pro-Activ Acne Creme out there. A quick search shows they seem to have Justin Bieber on their side... So it must be good :P
So does the Pro-activ designation mean you are putting probiotic yogurt on your face to reduce acne? Maybe this will be the next trend, remember the beer Shampoo fad. Of course it is on the Internet, so it must be true. Truth be known, the best cure for acne is to wash your face with a warm clean soapy facecloth 2 to 3 times a day. Ya know, after you eat. Typically speaking, grease will start to flow out of our pours after you eat so washing your face is the best cure for that. Eating all the Probiotic yogurt, dousing it down with Proactiv margarine and plastering your face with cream will not do as good a job as just washing.
Oh ya, the margarine companies have jumped onto the Proactiv bandwagon. There is now a Proactiv Becel margarine on the market which touts the use of Plant Sterols (Not Probiotic bacteria) to help reduce cholesterol levels. In addition to blocking the absorption of Cholesterol there is also an added risk of blocking the absorption of certain vitamins. This brings to mind a fad of the past, Olestra, which unlike Plant Sterols, is an artificial fat which is not absorbed by the body. Yet it still has the wonderful yummy melt in your mouth taste of good old Natural Fat. Now the next part almost made me piss myself laughing when I first read the warning label on a bag of Olestra Chips a friend "smuggled" across the Canadian Border. In addition to blocking the absorption of certain vitamins, this synthetic nummy Olestra caused anal leakage. Ya, you heard me right, they actually mentioned "Anal Leakage" on a bag of chips. Now doesn't that just make ya wanna run.... to the bathroom that is.
Anyways, back to the folks at Becel ant their brand new Plant Sterol Pro-Activ Margarine. Looking at the label, there appears to be no Probiotics, nor do I see any claimed that proactively rubbing Pro-Activ Plant Sterol margarine on your face will help prevent Justin Bieber from getting acne. So that brings up the question, What are Plant Sterols? Well, unlike Olestra, Plant Sterols occur naturally in foods such as nuts fruits and vegetables the kind added to food is usually derived from vegetable oil. The claim is that Plant Sterols reduce the absorption of Cholesterol, thus reducing the risk of heart attacks.
As for the risks of Plant Sterol, well there is the blockage of certain vitamins and People with sitosterolaemia are discouraged from using it as they are unable to metabolize plant sterols. There is, however, no mention of this on the label. I only see some instruction to consume at least 5 teaspoons of Plant Sterol containing Becel Margerine a day. Wow, that 227 Gram mini tub which cost me about 5 bucks will go quickly. I wonder if I can add chocolate syrup to it to make it taste better.

KING NUT PEANUT BUTTER RECALL over SALMONELLA OUTBREAK

KING NUT , An Ohio PEANUT BUTTER distributor issued a voluntary recall Saturday for two brands of PEANUT BUTTER after health officials in Minnesota on Friday said they had found SALMONELLA bacteria in a tub of PEANUT BUTTER that is distributed to schools and hospitals.

The recall, and the Minnesota report, could be the breakthrough in the search for the source of a SALMONELLA outbreak that has struck in 42 states so far.

Officials from the Minnesota Department of Health and the Minnesota Department of Agriculture issued a product warning Friday after preliminary laboratory testing indicated the presence of SALMONELLA in a container of creamy PEANUT BUTTER from KING NUT, according to published reports.

Late Saturday, KING NUT Companies of Solon, Ohio, announced it had issued a recall of all PEANUT BUTTER distributed under its label and manufactured by Peanut Corporation of America, of Lynchburg, Va. The company also recalled its distribution of PARNELL'S PRIDE PEANUT BUTTER, which is also made by Peanut Corporation, according to a prepared statement by KING NUT.

The company, in its statement, said it took the action after SALMONELLA was found in an open five-pound tub of KING NUT PEANUT BUTTER.

KING NUT distributes PEANUT BUTTER through food service accounts and does not sell it directly to consumers, the statement said.

The statement added, "KING NUT does not supply any of the ingredients for the PEANUT BUTTER distributed under its label. All other KING NUT products are safe and not included in this voluntary recall."

"We are very sorry this happened," said Martin Kanan, president and chief executive officer of KING NUT Companies. "We are taking immediate and voluntary action because the health and safety of those who use our products is always our highest priority."

KING NUT customers are asked to take all KING NUT PEANUT BUTTER and PARNELL'S PRIDE PEANUT BUTTER out of distribution immediately.

The recall and the potential link to the multi-state outbreak come two years after ConAgra recalled its Peter Pan brand PEANUT BUTTER, which had been linked to at least 625 SALMONELLA cases in 47 states.
U.S. health officials had formed a task force this week to seek the source of the latest outbreak, which began last fall and so far has sickened 399 Americans, according to the latest numbers issued Friday by the U.S. Centers for Disease Control and Prevention.

The strain of SALMONELLA has been identified as SALMONELLA Typhimurium, the most common of the more than 2,500 types of SALMONELLA bacteria in the United States. It's often found in uncooked eggs and meats, said officials with the CDC, who have been investigating the outbreak for several weeks.

"Cases are continuing to occur, and it is an ongoing investigation," Dr. Rajal Mody, a CDC Epidemic Intelligence Service officer, said earlier Friday. "The first people began getting ill in September, but it usually takes several weeks before enough cases have been reported to start noticing a possible outbreak."

Mody said he suspects a food item, possibly produce or a prepared packaged food.

"When you look at the distribution of cases, it does suggest that it could be a mass-distributed food," he said. "This outbreak is on the larger side, but there have been larger outbreaks."

Reports of people sickened have occurred between Sept. 3 and Dec. 29, 2008, with most illnesses starting after Oct. 1. About 18 percent of those who fell ill were hospitalized. Mody said he couldn't estimate when the outbreak might end, or how many people might eventually become infected with the germ.

SALMONELLA is typically transmitted through foods that are contaminated with animal feces, Mody said. As part of the investigation, federal health officials are interviewing infected people to see if there were common elements in their diet, he said.
Mody said most reported cases of SALMONELLA occur in children. In the current outbreak, victims have ranged in age from less than 1 year to 103, he said.

An estimated 40,000 cases of SALMONELLA infection are reported each year in the United States, but those are only the reported cases, Mody said. "Those are only the cases that are severe enough to have a person go to a doctor. It's been estimated that the actual number of total SALMONELLA cases could be 30 times or more as great," he said.

Mody said there probably have been many unreported cases in the current outbreak. "If someone has mild symptoms, they might not seek health care," he said.

Most people infected with SALMONELLA develop diarrhea, fever, and abdominal cramps within 12 to 72 hours after contact with the germ. Infections typically clear up in five to seven days, Mody said. "They often don't require any treatment other than making sure you take enough fluids," he said.

But, severe infections can occur, particularly in infants, the elderly, and people with weakened immune systems. In severe cases, the SALMONELLA infection can spread from the intestines to the bloodstream and other parts of the body, causing death unless antibiotics are administered, according to the CDC.

A SALMONELLA outbreak that began last April eventually sickened almost 1,400 Americans, sending nearly 300 of them to hospitals. The outbreak of Salmonella Saintpaul was later traced to jalapeno and serrano peppers imported from Mexico.

Lean Cuisine Recall

Utah-based Nestle Prepared Foods Company has recalled three varieties of frozen Lean Cuisine chicken meals, two of which were distributed in Oregon.

The entrees might contain small pieces of bright blue plastic, a high health risk, according to the U.S. Department of Agriculture's Food Safety and Inspection Service. Those meals are: Pesto Chicken with Bow Tie Pasta, Chicken Mediterranean and Chicken Tuscan, all produced between August 18 to October 27 and distributed to retail establishments nationwide.
The recall of roughly 1.2 million packages of food impacts Oregon shoppers who bought the products at Portland-area Albertsons stores and Clackamas Safeway stores.

One item -- the Pesto Chicken with Bow Tie Pasta, production code "8280595912" marked "Best Before MAY 2010" -- was not sold in Oregon, according to Nestle spokeswoman Roz O'Hearn.

But the other items were sold in Oregon.
Lean Cuisine Chicken Mediterranean, production code "8231595912" or "8241595912" marked "Best before SEP 2010"; production code "8263595912," "8269595911" or "8274595912," marked "Best before OCT 2010"; and production code "8291595912" or "8301595912" marked "Best before NOV 2010," were distributed locally at Albertsons in Portland and Safeways in Clackamas.

Lean Cuisine Chicken Tuscan, production code "8234595911" and marked "Best before SEP 2009"; production code "8253595911" or "8269595912" and marked "Best before OCT 2009"; and production code of "8292595911" or "8296595911" and marked "Best before NOV 2009," were distributed to Safeways in Clackamas.

Each package bears the USDA mark of inspection as well as the establishment number "EST P-9018."

Consumers with questions about the recall should contact Nestle Consumer Services Center at (800) 993-8625 or call the company's dedicated recall line at (800) 227-6188.

Nestlé Prepared Foods Company in Springville, Utah is recalling approximately 879,565 pounds of frozen chicken meals that may contain foreign materials, the U.S. Department of Agriculture’s Food Safety and Inspection Service said. The objects were identified as small pieces of hard plastic, which were discovered after the company received consumer complaints and a report of one injury.

The following products are subject to recall:

9.5-ounce packages of “Lean Cuisine Pesto Chicken with Bow Tie Pasta" brand frozen meals. Printed on each side of each package is a production code of “8280595912,” as well as a use-by date of “Best Before MAY 2010.”
10.5-ounce packages of “Lean Cuisine Chicken Mediterranean” brand frozen meals. Printed on the side of each package is a production code of “8231595912” or “8241595912,” as well as a use-by date of “Best before SEP 2010”; a production code of “8263595912,” “8269595911” or “8274595912,” as well as a use-by date of “Best before OCT 2010”; or, a production code of “8291595912” or “8301595912,” as well as a use-by date of “Best before NOV 2010.”
12.5-ounce packages of “Lean Cuisine Chicken Tuscan” brand frozen meals. Printed on the side of each package is a production code of “8234595911” and a use-by date of “Best before SEP 2009”; a production code of “8253595911” or “8269595912” as well as a use-by date of “Best before OCT 2009”; or, a production code of “8292595911” or “8296595911” as well as a use-by date of “Best before NOV 2009.”

Each package also bears the USDA mark of inspection, as well as the establishment number “EST P-9018.” The frozen chicken meals were produced on Aug. 18, Aug. 21, Aug. 28, Sept. 9, Sept. 19, Sept. 25, Sept. 30, Oct. 6, Oct. 17-18, Oct. 22 and Oct. 27 and were distributed to grocery stores nationwide

NUTRI SYSTEM and SWEET SUCCESS FUNDRAISING join the growing SALMONELLA RECALL LIST

More than 125 products have been recalled in an investigation into a deadly salmonella outbreak linked to peanut butter used in processed foods and in institutions, with dog biscuits and diet granola bars among the latest on a list that is growing. And growing.

"I don't think we can determine how many more" products will be recalled, Stephen Sundlof, director of the Center for Food Safety and Applied Nutrition at the Food and Drug Administration, said Wednesday. The outbreak has sickened hundreds and may have killed six people.

The FDA, the Centers for Disease Control and Prevention and state officials have traced sources of Salmonella typhimurium contamination to a plant in Blakely, Ga., owned by Peanut Corp. of America, which makes peanut butter and peanut paste made of ground, roasted peanuts.

Those products are distributed to food manufacturers to be used as ingredients in such processed foods as cakes, cookies, crackers, candies, cereal and ice cream. Peanut butter from the plant also is shipped to institutions, including long-term care facilities and cafeterias.


The company has stopped production at the Blakely plant, the FDA said.

Over the weekend, the CDC interviewed 57 people who had become ill, as well as hundreds of healthy, about what they had eaten, said Dr. Robert Tauxe of the CDC, who joined Sundlof in a telephone conference call with reporters.

Tauxe said information from the interviews led the agency to packaged peanut butter crackers. Additional investigation led to crackers that Kellogg Co. had recalled the day before those interviews took place.

On Sunday, Peanut Corp. expanded its voluntary recall to include more products and lot numbers of products from the plant manufactured on or after July 1. Company records of suppliers and customers have been turned over to federal authorities, Sundlof said.

Asked whether the Georgia plant was thought to be the sole source of the outbreak, Sundlof said, "That is our assumption at this point."

In its investigation of the outbreak, inspectors found salmonella at the Blakely plant, but it was a different strain than the one implicated in the illnesses, Sundlof said. One sample was found in a floor crack near the washroom. A second was found on the floor near some pallets.

Even though the strain is different, Sundlof said, "those salmonella are not supposed to be there."



In a statement released Wednesday, Peanut Corp. said it was cooperating with federal and state officials and working to ensure the safety of consumers.

"We will address the agency's findings when they are shared with us," it said.

Peanut Corp. buys peanuts from several sources, domestic and abroad; it buys some peanuts already roasted and roasts some itself, Sundlof said.

As of Wednesday, 486 people in 43 states and Canada, including 62 in California, had become sick from salmonella, which can cause diarrhea, nausea, vomiting and other problems.

Of those, 107 were hospitalized. Six deaths may be associated with the outbreak, Tauxe said. The most recent onset of illness was Jan. 8.

"More cases are being reported every day," he said. "The outbreak appears to be ongoing."

Major national brands of jarred peanut butter are not affected, the FDA said.

Peanut butter is used in "a huge variety" of foods, and tracking them down "is a very large and ongoing undertaking," Tauxe said.

If consumers cannot determine if a particular product contains any suspect ingredients, the FDA recommends they throw it out -- and do so in a way to prevent anyone else from eating the product. The agency has a searchable list of products and brands associated with the recall.


NutriSystem Inc., based in Horsham, Pa., on Wednesday announced a voluntary recall of some of its peanut butter granola bars because they contain peanut butter made by Peanut Corp.

"NutriSystem is no longer using PCA as a peanut butter supplier," the company said in a statement. The company also said none of its customers had reported problems.

The recall also includes seven PetSmart dog biscuit products. That company also said the move was precautionary and that it was unaware of any illnesses among pets that ate its products.

The risk to animals is minimal but possible, the FDA said. A pet could suffer fever, vomiting and other symptoms or show no symptoms but still infect others.

People who handle contaminated pet foods also could be at risk, the FDA said.

Sweet Success Fundraising in Ontario, also decided to take no chances and issued a voluntary recall, spokeswoman Lilly Ceja said Wednesday.

She said 170 tubs of frozen cookie dough sold to raise money for schools, distributed between Dec. 8 and Jan. 8, came from a company that used products on the list from Peanut Corp. She thinks the cookies already have been baked and eaten, but the few callers who contacted the company were told to toss out the dough and given refunds.

"If one person became ill from it, that's not acceptable," Ceja said. From now on, she added, Sweet Success will probably stick to raising money with wrapping paper or magazine sales.

BABY EINSTEIN RECALL - Discover and Play Color Blocks

Kids II, the makers of Baby Einstein, have recalled their Baby Einstein Discover & Play Color Blocks due to excessive lead paint. The Baby Einstein recall involves the Blue block in the Baby Einstein Discover & Play Color Blocks. According to the Baby Einstein Recall, the blue block Baby EinsteinDiscover & Play Color Block is painted with a lead based paint and is toxic for children to play with. Parents or caretakers should check their child's toys to see if the blue block effected by the Baby Einstein Recall is in there.

Here is the official release from Consumer Protection regarding the Baby Einstein Recall.

Kids II Recalls Baby Einstein Color Blocks Due to Violation of Lead Paint Standard
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.
Name of Product: Baby Einstein Discover & Play Color Blocks

Units: About 35,000

Distributor: Kids II Inc., of Alpharetta, Ga.

Hazard: Surface paint on the blue block contains excessive levels of lead, violating the federal lead paint standard.

Incidents/Injuries: None reported.
Description: The recall involves the blue block included with the Baby Einstein Discover & Play Color Blocks, Model 30726 and Model 30881. The blocks are made of soft textures and come in different colors. Only date codes of GE7, GF7, and GG7 are included in this recall. The model number and date code are printed on the labels affixed to the green-colored block.

Sold at: Various retailers and specialty stores nationwide from June 2007 through September 2007 for between $10 and $13.

Manufactured in: China

Remedy: Consumers should take the recalled blue block away from children immediately and contact Kids II to receive a free replacement of the affected block.

Consumer Contact: For additional information, contact Kids II toll-free at (866) 203-6788 between 7:30 a.m. and 4:30 p.m. ET Monday through Friday, or visit the firm’s Web site at www.kidsii.com

Here is an article I pulled from Keepkidshealthy.com on the signs and effects of lead poisoning.

After being ingested, lead enters the bloodstream and is absorbed and stored in many tissues and organs in the body, including the liver, kidneys, brain, teeth and bones.
High levels of lead can cause serious health problems in your children. Lead poisoning can affect almost every organ system of the body, including:

brain and central nervous system, causing:
lower IQs
headaches
memory problems
reduced coordination
learning disabilities
irritability
hyperactivity
increased sleeping
decreased activity and fatigue
hearing loss
vomiting
slow reflexes
muscle weakness, affecting mainly the upper extremities
seizures, coma, hypertension in high levels
gastrointestinal system, causing:
constipation
diarrhea
abdominal pain
vomiting
poor appetite
weight loss
blood system, causing anemia or low blood counts
kidney problems
reproductive system, causing:
miscarriages
premature birth
low birth weight
If your child has any of these symptoms of lead poisoning and he is at risk for lead exposure then you should see your doctor immediately. Most children with lead poisoning do not have any symptoms, so if your child is at risk you should still have him tested even if he is not having any problems.

Some effects of lead poisoning, such as poor school performance because of a low IQ, do not show up until a child is much older, at which time they will probably have a normal lead level, and so may not be attributed to lead poisoning.

CHILDRENS TYLENOL RECALL 2009

Tylenol has been hit bad with bad product recalls, particularly Childrens Tylenol. This recent recall announced on APril 30, 2010 is not the first recall of Childrens' Tylenol Products.

This time, the Childrens Tylenol Recall is a Voluntary recall on behalf of McNeil Consumer Health, the makers of the recalled Childrens Tylenol. McNeil's website cites quality standards on their website when mentioning the recall of Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

Below is the Press release regarding the Childrens Tylenol recall from the McNeil Consumer Health website including a text list of all the Products they listed as effected by the Childrens Tylenol recall. McNeil posted an image on their website, I figured it was only fair to the parents involved to convert the list to text. Just in case there are any discrepancies, I have also included the Image of Childrens Tylenol products effected by the April 30 2010 Childrens Tylenol Recall, as it also contains lot numbers.




Fort Washington, PA (April 30, 2010) – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. (SEE RECALLED PRODUCT LIST BELOW).

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.

The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.

Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com. Parents and caregivers who are not sure about alternative pediatric health treatment options should talk to their doctor or pharmacist and are reminded to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm.

For additional information, including affected NDC numbers, consumers should visit our website www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. markets a broad range of well-known OTC products.

Tylenol Infants Drops

Concentrated Tylenol Infants' drops 1 OZ grape flavour
Concentrated Tylenol Infants' drops 0.5 oz grape flavour
Concentrated Tylenol Infants' drops 1 oz Cherry dye free
Concentrated Tylenol Infants' drops 0.5 oz Cherry flavour
Concentrated Tylenol Infants' drops 1 oz Cherry Flavour
Concentrated Tylenol Infants' drops 0.5 oz grape Hospital
Concentrated Tylenol Infants' drops 0.25 oz Grape Sample

Childrens Tylenol Suspensions

Childrens Tylenol Suspension 2 Oz Cherry Blast
Childrens Tylenol Suspension 4 Oz Cherry Blast
Childrens Tylenol Suspension Dye Free 4 Oz Cherry
Childrens Tylenol Suspension 4 Oz Grape Splash
Childrens Tylenol Suspension 4 oz bubblegum
Childrens Tylenol Suspension 4 oz very berry strawberry
Childrens Tylenol Suspension 1 Oz Cherry Blast Sample
Childrens Tylenol Suspension 4 Oz Cherry Blast Hospital

Childrens Tylenol Plus Suspensions

Childrens Tylenol Plus Suspension 4 oz cough sore throat cherry flavour
Childrens Tylenol Plus Suspension 4 Oz Cough runny nose cherry
Childrens Tylenol Plus Suspension dye free 4 oz cold stuffy nose grape
Childrens Tylenol Plus Suspension Dye free 4 oz cold and cough grape
Childrens Tylenol Plus Suspension Dye free 4 oz multi symptom cold grape
Childrens Tylenol Plus Suspension 4 oz flu bubblegum
Childrens Tylenol Plus Suspension 4 oz cold grape
Childrens Tylenol Plus Suspension 4 oz cold and Allergy bubblegum
Childrens Tylenol Plus Suspension 4 oz multi symptom cold grape

Motrin Infants' drops

Concentrated Motrin Infants Drops 1 Oz Berry Dye Free
Concentrated Motrin Infants Drops 0.5 Oz Berry Dye Free
Concentrated Motrin Infants Drops 0.5 Oz Berry

Childrens Motrin Suspensions

Childrens Motrin Suspension 4 Oz Berry Dye Free
Childrens Motrin Suspension 2 Oz Berry
Childrens Motrin Suspension 4 Oz Berry
Childrens Motrin Suspension 4 Oz Tropical Punch
Childrens Motrin Suspension 4 Oz Grape
Childrens Motrin Suspension 4 Oz Bubblegum
Childrens Motrin Suspension 1 Oz Grape Sample
Childrens Motrin Suspension 1 Oz Bubblegum Sample
Childrens Motrin Suspension 1 Oz Berry Sample

Childrens Motrin Cold Suspensions
Childrens Motrin Suspension 4 oz Cold Berry Flavour

Childrens Zyrtec Liquid in Bottles

Childrens Zyrtec Sufar free dye free 4 Oz Bubblegum syrup
Childrens Zyrtec Sufar free dye free 4 Oz Grape Syrup
Childrens Zyrtec Sufar free dye free 0.5 Oz Grape
Childrens Zyrtec Sufar free dye free 0.5 Oz Bubblegum
Childrens Zyrtec Sufar free dye free 2 x 4 Oz Bubblegum Liquid

Childrens Benadryl Allergy Liquid in Bottles

Childrens Benadryl Allergy 4 Oz Sugar Free Dye Free Bubblegum flavoured liquid

* CONCENTRATED Tylenol Infants' drops 0.5 Oz Grape Flavour is also included in Johnson's Baby Relief kit.

* CONCENTRATED Motrin Infants' drops 0.5 Oz Berry Dye Free Flavour is also included in Johnson's Baby Relief kit.