Source | FDA

Brooklyn, NY — August 14, 2007 — Acme Smoked Fish Corporation is voluntarily recalling 132 lbs of 4 oz. Smoked Salmon (Acme NY Original) and 114 lbs of 8 oz. Smoked Salmon (Acme NY Original) with a batch code of 9428 and sell-by-date code of 9-26/2007. This product was distributed to retail stores in the South Florida Region.

The potential for contamination was noted after routine testing by the Florida Department of Agriculture and Consumer Services revealed the presence of Listeria monocytogenes in one 4 ounce package of “4 oz. Smoked Salmon (Acme Y Original)” with product code 9428 and sell-by-date code of 9/26/07. This organism can cause serious complications for pregnant women, young children, frail or elderly people, and others with weakened immune systems.

No illnesses have been reported to date in connection with this problem.

FDA has important new information about a very rare, but serious, side effect in nursing infants whose mothers are taking codeine.  Differences in drug metabolism among mothers taking codeine may contribute to side effects in nursing infants.

Infants of nursing mothers taking codeine may have an increased risk of morphine overdose if the mother is an ultra-rapid metabolizer of codeine.  When codeine enters the body and is metabolized, it changes to morphine, which relieves pain.  Many factors affect codeine metabolism, including a person’s genetic make-up.  Some people have a variation in a liver enzyme and may change codeine to morphine more rapidly and completely than other people.  These people are ultra-rapid metabolizers and are more likely to have higher than normal levels of morphine in their blood after taking codeine.  Nursing mothers taking codeine may also have higher morphine levels in their breast milk.  These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies.  In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer.

Codeine has been used safely for many years in nursing mothers.  Codeine is an ingredient in many prescription pain relievers and some over-the-counter cough syrups.
Once the body changes codeine to morphine, the morphine relieves the pain or cough and may also be responsible for any side effects people may experience.  Infants exposed to very high levels of morphine through breast milk can get a morphine overdose as described below.

Last year, a medical journal described a healthy 13-day-old breastfed baby who died from a morphine overdose.  The mother was taking less than the usual amount of codeine normally prescribed for episiotomy pain (Koren, et al, Lancet, vol 368 p. 704, Aug 2006).  Laboratory tests showed high levels of morphine in the baby’s blood, and genetic testing showed that the baby’s mother was an ultra-rapid metabolizer of codeine.

FDA is issuing this public health advisory to inform healthcare professionals and nursing mothers about the following important safety information:

• When prescribing codeine for a nursing mother, doctors should prescribe the lowest dose for the shortest amount of time to relieve pain or cough.  Doctors need to tell their nursing patients how to recognize signs of high morphine levels in themselves and their babies.

• If you are a nursing mother taking codeine, call your doctor if you become extremely sleepy and have trouble caring for your baby.

• Breastfed babies usually nurse every two to three hours and should not sleep more than four hours at a time.  If your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, talk to the baby’s doctor immediately.  If you cannot reach the doctor right away, take the baby to an emergency room or call 911 (or local emergency services).

• Nursing mothers should talk to their doctors if they have any questions about taking codeine.

The estimated number of ultra-rapid metabolizers varies among different population groups from less than 1 per 100 people up to 28 per 100 people.  For people who are ultra-rapid metabolizers, the risk of having an adverse event when taking codeine is not known.

Anyone can be an ultra-rapid metabolizer without knowing it.  The only way to find out is with a genetic test.  There is a FDA-cleared test to determine whether a patient is an ultra-rapid metabolizer, but there is limited information about using this test for codeine metabolism.   At this time, the test result alone may not correctly predict if a mother’s breast milk will have too much morphine if she uses codeine to treat pain.  This test isn’t a substitute for a doctor’s judgment.

Among pain relievers, ultra-rapid metabolism has only been reported as a problem with codeine, although it has the potential to affect other narcotics.  All narcotics can cause the same serious side effects in breastfed babies if the levels of drug in breast milk are too high.

FDA has asked the makers of prescription codeine-containing products to include information about differences in codeine metabolism and concerns with breastfeeding in the drug label.  Use of codeine products to manage pain after birth is common, but reports of serious side effects in nursing infants are very rare.  Doctors who prescribe codeine need to be aware of the potential for the increased risks to breastfeeding babies of mothers who are ultra-rapid metabolizers of codeine.

The FDA urges healthcare providers and nursing mothers to report side effects that occur while using codeine to the FDA’s MedWatch Adverse Event Reporting program.

Source | FDA

Philadelphia, PA — August 16, 2007 — Ocean King Enterprises Inc. of Philadelphia, PA is recalling Ready-to-Eat Seafood Dips, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

Products were distributed through the following A&P warehouses: A&P (C&S) Hatfield in Hatfield, MA; A&P (C&S) Baltimore in North East, MD; and A&P (C&S) Woodbridge in Woodbridge, NJ. Products will have reached consumers through retail stores from warehouse distribution.

The products were sold in bulk 5-pound containers to the warehouses. The dips are then sold in the value added and deli sections of the retail stores in clear plastic containers with a Regal King label. All flavors have a red and white repack label. The brand name is Regal King Gourmet Seafood. The flavors are Premium Krab Dip, Cajun Krab Dip, Shrimp Dip, and Smoked Salmon Dip.

No illnesses have been reported to date.

The recall was the result of an independent systemic sampling program conducted by Ocean King Enterprises Inc. which revealed that one finished product contained the bacteria. The company has ceased the production and distribution of the product as FDA and Ocean King Enterprises continue their investigation as to what caused the problem.

Seafood Dip Recall List

Regal King Premium Krab Dip
Regal King Cajun Krab Dip
Regal King Shrimp Dip
Regal King Smoked Salmon Dip

Source | CNN.com

Toymaker Mattel is voluntarily recalling 9 million of its toys including popular characters such as Batman, Barbie, Polly Pockets and a toy from Pixar’s “Cars” movie because of hazards to children, the U.S. Consumer Product Safety Commission said Tuesday.

“The company has ordered that all products be pulled off retail shelves,” said Nancy Nord, acting chairman of the commission.

The affected toys include Barbie Doll and Tanner dolls, Batman Magna series action figures, and Polly Pocket playsets. The commission says they have small, powerful magnets that can be dislodged and swallowed.

All of the toys were manufactured in China.

Read the full text: http://www.cnn.com/2007/US/08/14/recall/index.html

Source | Yale University School of Medicine

Nephrogenic systemic fibrosis (NSF), also known as nephrogenic fibrosing dermopathy, is a scleroderma-like disease of the skin observed in patients with renal insufficiency.

Since its recognition in 1997, relatively little has been published in the nephrology literature, despite indications that the disorder is becoming increasingly recognized in the United States and abroad. As nephrology professionals may be the first to encounter newly developing cases of NSF, it becomes imperative that they be able to recognize the symptoms and comorbidities and initiate tests and treatment.

To date, the cause of NSF has not been established. Recent observations indicate that specific cells normally involved in wound repair and tissue remodeling may be aberrantly recruited to the skin and soft tissues of NSF patients.

UPDATE: Nephrogenic Systemic Fibrosis (NSF) and/or Nephrogenic Fibrosing Dermopathy (NFD) is a serious, life-threatening skin disorder, which has recently been linked to the use of gadolinium-based contrast agents during MRI or MRA procedures. 

Learn More: http://www.schmidtandclark.com/Gadolinium/

Source | FDA

Warning Follows Bacterial Illness Outbreak

The U.S. Food and Drug Administration is warning consumers not to eat raw oysters harvested from an area of the southern tip of Hood Canal in Washington  after an outbreak of illness caused by Vibrio parahaemolyticus bacteria.

Symptoms of Oyster Induced Food Poisoning

Symptoms of the illness, called vibriosis, include watery diarrhea, often with abdominal cramping, nausea, vomiting, fever, and chills. Usually these symptoms occur within 24 hours of ingestion and last no more than three days. Severe disease is rare and occurs most commonly in people with weakened immune systems. Those who believe they have experienced these symptoms after consuming raw oysters should consult their health care provider and contact their local health department.

What’s the problem?

Raw oysters harvested from “growing area 6” in Hood Canal from July 3, 2007 and after, have caused at least six people to become ill in California and Washington. Additional reports of illness are being investigated by the states. To date, records indicate that raw oysters from the area were distributed to California, Florida, Hawaii, Idaho, New York, Oregon, Washington, British Columbia (Canada), Hong Kong, Malaysia, and Singapore.

What’s being done?

The Washington State Department of Health has closed the growing area associated with the illness and has asked commercial oyster harvesters and dealers who obtained oysters from this area to recall them. Consumers who have recently purchased oysters should check with the place of purchase and ask if they were harvested from the affected growing area.

Who’s at risk?

All consumers that eat the aforementioned are at risk, howerver those with weakened immune systems, including people affected by AIDS, chronic alcohol abuse, liver, stomach, or blood disorders, cancer, diabetes, or kidney disease should avoid eating raw oysters, regardless of where they are harvested.

How to Prepare Oysters Safely

FDA advises that consumers can continue to enjoy oysters in many cooked preparations by doing the following:

At Restaurants and other Foodservice Establishments:

Order oysters fully cooked.

In the Shell:

Purchase oysters with the shells closed.
Throw away any oysters with shells already opened.
Never allow raw seafood to come into contact with cooked food.
Boil oysters until the shells open. Once shells open, boil for an additional three to five minutes.
To steam—add oysters to water that is already steaming and cook live oysters until the shells open, once open steam for another four to nine minutes.

Use smaller pots to boil or steam oysters. Using larger pots, or cooking too many oysters at one time, may cause uneven heat distribution, which may cause the oysters in the middle to be under-cooked.
Discard any oysters that do not open during cooking.
Shucked Oysters:

Never allow raw seafood to come into contact with cooked food.
Boil or simmer shucked oysters for at least three minutes or until the edges curl.
Fry at 375 F for at least three minutes.
Broil three inches from heat for three minutes.
Bake at 450 F for 10 minutes

Shellfish growing areas close due to vibriosis outbreak

Source | Washington State Department of Health

OLYMPIA, WA — Oysters harvested from Hood Canal have been connected to six cases of vibriosis in California resulting in the closure of two growing areas at the southern tip of the canal.

The Department of Health has closed shellfish beaches in Mason County from Miller Creek (north of Hoodsport) south and east to Sunset Beach and across to Stimson Creek. The closed areas include both Potlatch and Twanoh state parks.

In addition, the department is asking the shellfish industry to recall oysters from these growing areas. Consumers who may have purchased oysters from these areas should check with the place of purchase to see if they were harvested from the affected growing areas.

Vibriosis is caused by a naturally occurring bacterium, Vibrio parahaemolyticus. Symptoms include diarrhea, abdominal cramps, nausea, vomiting, headache, fever, and chills and usually appear about 12 hours after eating infected shellfish. The illness is usually mild to moderate and lasts for two to seven days; it can be life threatening to people with immune dysfunction or chronic liver disease. Unseasonably warm temperatures and afternoon low tides are thought to be major contributors to this outbreak.

The best way to prevent this illness is to cook your oysters during the warm summer months. The bacteria are killed when oysters are cooked to 145� F.

The only way to be safe is to “Know Before You Dig.” The Department of Health recreational shellfish map Web site (www.doh.wa.gov/biotoxinmaps.htm), state shellfish program (360-236-3330), and local health agencies are excellent sources of information.

Source | Associated Press | Jeffrey Gold

Importer Recalls 255,000 Chinese Tires

A tire importer said Thursday it would recall 255,000 Chinese-made tires it claims were defective because they lack a safety feature that prevents tread separation.

The recall involves half the number of tires that the importer, Foreign Tire Sales Inc., had identified in June as possibly posing a risk.

The models involved are steel-belted radial replacement tires for pickups, vans and sport utility vehicles that consumers bought from early 2004 through mid-2006, Foreign Tire Sales said.

The small company, based in Union, estimated the recall would cost it $20 million, spokesman Andrew D. Frank said. It was ordered by the National Highway Traffic Safety Administration in June to recall as many as 450,000 tires that it bought from Hangzhou Zhongce Rubber Co. since 2002.

“Consumers should know that the affected tires meet all federal motor vehicle safety standards. But we went the extra mile by testing them and determining that they did not meet our standards, which are more rigorous,” Richard Kuskin, president of Foreign Tire Sales, said in a statement.

Hangzhou Zhongce said it fully cooperated with NHTSA and “has not found any evidence that the … tires at issue contain any structural defects or are missing any safety features.”

The recall is among a series of recent problems involving imports from China. Products including toys, toothpaste, seafood and pet food have been recalled.

The recall applies to Westlake, Compass and YKS brand tires in these sizes and models:

_Size LT235/75R-15, models CR861 and CR857, with a DOT number beginning 7DT5FTS.

_Size LT235/85R-16, models CR860, CR861 and CR857, with a DOT number beginning 7DT2FTS.

_Size LT245/75R-16, models CR860, CR861 and CR857, with a DOT number beginning 7DT3FTS.

_Size LT265/75R-16, models CR860, CR861 and CR857, with a DOT number beginning 7DT4FTS.

_Size LT31X10.5 R-15, models CR857 and CR861, with a DOT number beginning 7DT6FTS.

Although Foreign Tire Sales did not make the tires, it is responsible for the recall, under U.S. law.

NHTSA ordered the recall after Foreign Tire Sales told the agency that some of Hangzhou Zhongce’s tires were made without a safety feature, called a gum strip, that helps bind the belts of a tire to each other. Some of the tires had a gum strip about half the width of the 0.6 millimeter gum strip Foreign Tire Sales expected, the importer said.

It said it contracted for Hangzhou Zhongce to provide gum strips, but the manufacturer changed the design without informing Foreign Tire Sales.

Hangzhou Zhongce has denied that, asserting that the design did not include a gum strip. It also called the basis for the defect determination by Foreign Tire Sales “highly questionable.”

The manufacturer has also told NHTSA that it has received just 11 claims for property damage from the nearly 450,000 tires purchased by Foreign Tire Sales, a rate it called “extremely low.” The repairs averaged $1,722, “which is consistent with minor fender well damage,” Hangzhou Zhongce said.

Hangzhou Zhongce also said it paid just 1,540 warranty claims for such items as ride disturbance and sidewall issues, which are not related to the alleged defect.

The details of the recall come a month later than Foreign Tire Sales had initially expected. Frank, the company spokesman, attributed the delay to gathering information from the manufacturer.

“The recall was complicated,” he said.

Tread separation was what prompted the nation’s largest tire recall, which involved 17 million Firestone tires in 2000.

Foreign Tire Sales alerted federal authorities of potential problems after it became embroiled in litigation involving the tires and Hangzhou Zhongce.

Foreign Tire Sales said it became concerned about Hangzhou Zhongce tires in October 2005 amid an increase in warranty claims. It began talks with the Chinese company, then commissioned its own tests.

It sued Hangzhou Zhongce in U.S. District Court in Newark on May 31, charging that its tests found that the tires may fail earlier than tests provided by Hangzhou Zhongce showed.

Foreign Tire Sales was sued May 4 by the families of two men killed when a van they were riding in crashed near the town of Jim Thorpe, Pa., in August 2006. The driver and another passenger in the van are also suing.

Hangzhou Zhongce said it made three of the four tires on the van, but they were not the recommended size for that vehicle. The fourth tire, a Michelin (other-otc: MGDDF.PK - news - people ), was the proper size, but mismatched tires pose a risk, the Chinese company said. The company added that it has not yet been allowed to examine the vehicle and does not know if the accident was caused by tire failure.

Foreign Tire Sales does not have a warehouse. It has tires shipped directly to distributors, who in turn send them to retail outlets.

Source | FDA

Early Communication About an Ongoing Safety Review
Omeprazole (Prilosec)
Esomeprazole (Nexium)

FDA has received and is reviewing new safety data about Prilosec (omeprazole) and Nexium (esomeprazole).  On May 29, 2007, AstraZeneca, the manufacturer of Prilosec (omeprazole) and Nexium (esomeprazole), sent FDA and other regulatory authorities world-wide their preliminary review of new data from two small long-term clinical studies in patients with severe gastroesophageal reflux disease (GERD).  In both studies, patients were to be randomly assigned to receive treatment with a drug (either omeprazole or esomeprazole) or to have surgery to control their GERD.  The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery.

Since May 29, the company has provided FDA with a large amount of additional data, including more information on patient follow-up from the two long-term studies mentioned above, and pooled analyses of other controlled clinical studies, including placebo-controlled trials of up to two-year’s duration. At this time, FDA’s preliminary conclusion is that collectively, these data do not suggest an increased risk of heart problems for patients treated with omeprazole or esomeprazole.  Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of these products at this time.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.  FDA plans to complete its review within three months, and will communicate its conclusions and any resulting recommendations to the public at that time.

What does FDA know now about these data? 

A 14-year study comparing treatment with the drug omeprazole to surgery in patients with severe GERD found that more patients treated with omeprazole had heart attacks, heart failure, and heart-related sudden death than did the patients who had surgery.  The difference between the two groups of patients was seen within the first year of the study, and continued over time.  A second, still ongoing, study comparing esomeprazole to surgery had five year follow-up information on patients.  While the initial data from this study suggested a difference between treatments in the rate of cardiovascular events, an updated report submitted by AstraZeneca found that the number of patients who experienced heart problems was similar in both treatment groups.

While both of these studies collected safety data, the study protocols did not specify how heart problems, such as heart attacks, were to be defined or documented.  As a result, evaluating the information that has been gathered about the safety of either drug in these studies is difficult.

Also, many of the patients who were randomized to the group that was to have surgery withdrew from the study without ever undergoing the surgical procedure.  The patients who did undergo surgery tended to be younger, and less likely to have a past history of heart problems or risk factors for heart problems, than those who were treated with one of the drugs.  These differences between the two groups of patients could have biased and significantly influenced the safety data from these studies.

Finally, FDA’s preliminary conclusion about the information from these two studies is further supported by an additional analysis of 14 comparative studies of omeprazole, of which four were placebo-controlled.  Patients in these studies were treated for up to two years.  In these studies, there were fewer heart attacks or other heart problems reported in the patients treated with omeprazole compared to patients that were given a placebo. Although these studies were not specifically conducted to assess the risk of heart problems, and patient follow-up is incomplete, they do not suggest an increased risk of heart problems with the use of omeprazole. FDA will continue its review of all available data.

Based on everything we know now, FDA’s preliminary conclusion is that the observed difference in risk of heart attacks and other heart related problems seen in early analyses of the two small long-term studies is not a true effect.

Prilosec and Nexium are members of a class of drugs called proton pump inhibitors (PPIs) and work by reducing the amount of acid produced by the stomach. Both drugs are used for the treatment of gastroesophageal reflux disease (GERD) including a condition where the lining of the esophagus wears away (erosions), and for maintenance of healing erosions of the esophagus. They are also used for the treatment of ulcers. Prilosec (omeprazole) and Nexium (esomeprazole) are available by prescription. Prilosec is also sold over-the-counter for frequent heartburn.

Source | FDA

Baxter Provides Update on Service Documentation Class I Recall

Models Include: COLLEAGUE Mono Volumetric Infusion pump, Product Codes 2M8151 and 2M8153; COLLEAGUE CX Volumetric Infusion pump, Product Codes 2M8161 and 2M8163; FLO-GARD 6201 Volumetric Infusion pump, Product Code 2M8063; and FLO-GARD 6301 Volumetric Infusion pump, Product Code 2M8064

FOR IMMEDIATE RELEASE — Baxter Healthcare Corporation today announced an update to the July 25, 2007 Class I recall press release regarding falsified repair, test and inspection data sheets, which included electrical safety data for COLLEAGUE and FLO-GARD infusion pumps. Baxter has expanded the recall to include an additional 986 COLLEAGUE infusion pumps, which need to be returned to the company for repeat inspection, because of falsified electrical safety data.

As announced on July 25, 2007, in the course of its ongoing quality control processes, the company discovered falsified service documentation data. Therefore, it is possible that pumps sent to be serviced, repaired or corrected were returned without service being performed on them. Previously, the recall pertained to 534 infusion pump devices serviced in the company’s Phoenix, Arizona service center. The expansion of the recall represents pumps serviced by all three employees previously mentioned who have been dismissed. Baxter’s investigation of the matter is continuing. The company will continue to provide updates and instructions to users regarding the service documentation recall on www.baxter.com.

The company has informed all customers to contact Baxter and return affected pumps for repeat inspection and servicing and will provide loaner pumps free of charge. There are no serious injuries or patient deaths associated with this action to date. This recall action impacts only pumps distributed in the United States.

This issue was classified by FDA as a Class I recall on July 24, 2007, because of the potential risk of serious injury or patient death if affected devices malfunction. A defect may result in over-infusion, under-infusion, failure to detect an upstream or downstream occlusion, electrical shock hazard, failure to detect air in line, and malfunctions where the pump will stop infusing and result in an interruption of therapy. Affected model numbers include: FLO-GARD Model Numbers 6201 and 6301 Volumetric Infusion pump, Product Codes: 2M8063 and 2M8064; COLLEAGUE Volumetric Infusion pump, Product Codes: 2M8151 and 2M8153; and COLLEAGUE CX Volumetric Infusion pump, Product Codes: 2M8161 and 2M8163. The Agency is expected to issue a Preliminary Public Health Notification on Baxter’s service documentation recall.

Source | FDA

Product Marketed Under a Variety of Brand Names

The U.S. Food and Drug Administration (FDA) is warning consumers not to eat certain brands of French Cut Green Beans in 14.5 ounce cans manufactured by Lakeside Foods Inc, of Manitowoc, Wisconsin because the product may not have been processed adequately to eliminate the potential for botulism toxin. This warning is not related to another recent warning for botulism.

The canned green beans may cause botulism if consumed.  FDA is providing this warning to make consumers aware of the possible risk of serious illness from eating these products. As of August 1, 2007, FDA had not received reports of illnesses related to the product.

The botulism toxin is very potent, and botulism is a life-threatening illness.  Symptoms of botulism can begin from six hours to two weeks after eating food that contains the toxin. The symptoms may include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth, and muscle weakness that moves progressively down the body, affecting the shoulders first then descending to the upper arms, lower arms, thighs, and calves. Botulism also may cause paralysis of the breathing muscles, which can result in death unless assistance with breathing (mechanical ventilation) is provided.  Individuals who show these symptoms and who may have recently eaten the product should seek immediate medical attention.

The affected Lakeside cut green beans are sold nationwide under the following labels: Albertson’s, Happy Harvest, Best Choice, Food Club, Bogopa, Valu Time, Hill Country Fare, HEB, Laura Lynn, Kroger, No Name, North Pride, Shop N Save, Shoppers Valu, Schnucks, Cub Foods, Dierbergs, Flavorite, IGA, Best Choice and Thrifty Maid.  The specific codes (top line of can code) involved are: EAA5247, EAA5257, EAA5267, EAA5277, EAB5247, EAB5257, ECA5207, ECA5217, ECA5227, ECA5297, ECB5207, ECB5217, ECB5227, ECB5307.

Consumers who have any of these products or any foods made with these products should dispose of them immediately. If the code on an affected can is missing or unreadable, consumers should throw the product out.

Lakeside Foods has informed FDA that it is voluntarily recalling all of the potentially contaminated products.