Seven Manufacturers Announce Recalls to Repair Cribs to Address Entrapment, Suffocation and Fall Hazards
Industry Launches New Initiative to Secure Drop Sides with Free Immobilization Devices
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC), with the cooperation of seven firms, is announcing voluntary recalls of more than two million cribs to address drop-side hazards and other hazards that affect the safety of young children. The recalling firms are providing consumers with free repair kits to immobilize the drop sides or other remedies. Do not attempt to fix these cribs with homemade remedies.
The drop-side and fixed-side crib recalls announced today are of units manufactured between 2000 and 2009 by the companies listed below. Consumers should contact these firms directly for the appropriate remedy:
Child Craft, (this firm is out of business): Fixed-Side | Drop-Side
Delta Enterprise Corp., of New York, N.Y.
Evenflo, of Miamisburg, Ohio
Jardine Enterprises, of Taipei, Taiwan
LaJobi, of Cranbury, N.J.
Million Dollar Baby, of Montebello, Calif.
Simmons Juvenile Products Inc. (SJP), of New London, Wis.
“Cribs should be the safest place in the home for infants and toddlers,” said CPSC Chairman Inez Tenenbaum. “CPSC is committed to addressing the hazards with cribs and to restoring parents’ confidence that their child will have a safe sleep.”
CPSC continues to actively investigate various cribs for potential drop-side and other hazards as part of a larger effort by the agency to rid the marketplace and homes of unsafe cribs. CPSC staff is also working on a new mandatory standard to make cribs safer, which is targeted for completion in 2010.
The Juvenile Products Manufacturers Association (JPMA) has also launched a new crib safety initiative. The listed manufacturers are providing free drop-side crib immobilization kits to prevent the drop side from detaching, plus replacement hardware and assembly instructions for cribs manufactured by participating firms. These materials are available free to any consumer by request.
The firms involved in today’s recalls are providing immobilization devices or other remedies as part of JPMA’s crib safety initiative. Consumers can visit JPMA’s website, www.cribsafety.org, for a list of participating manufacturers and for downloadable materials about ensuring that children have a safe sleep.
The immobilization devices, which will be available in the next few weeks, should be attached to keep the drop side from detaching from the cribs. Immobilization devices are not a solution for cribs with broken or damaged drop-side hardware. If your drop-side hardware is broken, contact the manufacturer for an alternative remedy.
CPSC issued a warning last month alerting parents and caregivers that there can be deadly hazards associated with drop-side cribs. Nine million drop-side cribs have been recalled over the past five years. CPSC staff has determined drop-side cribs generally have a tendency to be less structurally sound than cribs with four fixed sides.
Drop-side crib incidents can also occur due to incorrect assembly or age-related wear and tear. Age is a factor in the safety of any crib. At a minimum, CPSC staff recommends that you not use a crib that is older than 10 years. Many older cribs do not meet current voluntary standards and can have numerous safety problems.
Important Message from CPSC:
The safest place for your baby to sleep is in a crib or bassinet depending on their age. If your crib has been recalled or it has missing, broken or loose parts, find an alternate safe sleep environment intended for a baby. If your baby is less than six months old and is not yet able to push up to his/her hands and knees, you can put your baby to sleep in a bassinet. Make sure your bassinet has not been recalled. Here’s a list. Also, you can use a play yard.
Do not put additional bedding such as pillows, thick quilts, comforters or anything plush into your baby’s sleeping space. More babies die every year from suffocation in plush sleeping environments than from defective cribs. Always place your baby on his or her back to reduce the risk of Sudden Infant Death Syndrome (SIDS).
Thursday, June 24, 2010
Tuesday, June 15, 2010
Vitamin D Supplement Products: Medication Use Error
Vitamin D Supplement Products: Medication Use Error
Audience: Pediatrics, Family Practice, Consumer
ISSUE: Some liquid Vitamin D supplement products are sold with droppers that could allow parents to accidentally give harmful amounts of Vitamin D to their infant. Excessive amounts of Vitamin D can be harmful to infants, and may be characterized by nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences like kidney damage.
BACKGROUND: The American Academy of Pediatrics has recommended a dose of 400 International Units (IU) of Vitamin D Supplement per day to breast-fed and partially breast-fed infants (AAP Pediatric Nutrition Handbook, 6th edition, p.466).
RECOMMENDATION: The easiest way to insure that an infant will not get more than the recommended dose is to use a product supplied with a dropper that will give no more than 400 IU per dose. If a caregiver cannot clearly determine the dose of Vitamin D that should be given to an infant or has any other questions, FDA recommends consulting with a healthcare provider before giving any of these products to an infant.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Online: www.fda.gov/MedWatch/report.htmPhone: 1-800-332-1088
Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
Fax: 1-800-FDA-0178
Audience: Pediatrics, Family Practice, Consumer
ISSUE: Some liquid Vitamin D supplement products are sold with droppers that could allow parents to accidentally give harmful amounts of Vitamin D to their infant. Excessive amounts of Vitamin D can be harmful to infants, and may be characterized by nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences like kidney damage.
BACKGROUND: The American Academy of Pediatrics has recommended a dose of 400 International Units (IU) of Vitamin D Supplement per day to breast-fed and partially breast-fed infants (AAP Pediatric Nutrition Handbook, 6th edition, p.466).
RECOMMENDATION: The easiest way to insure that an infant will not get more than the recommended dose is to use a product supplied with a dropper that will give no more than 400 IU per dose. If a caregiver cannot clearly determine the dose of Vitamin D that should be given to an infant or has any other questions, FDA recommends consulting with a healthcare provider before giving any of these products to an infant.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Online: www.fda.gov/MedWatch/report.htmPhone: 1-800-332-1088
Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
Fax: 1-800-FDA-0178
Friday, June 11, 2010
FDA Seizes More Than $32,000 Worth of Bulk Honey from Philadelphia Distribution Center
Media Inquiries: Elaine Gansz Bobo, 301-796-7567, elaine.bobo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Seizes More Than $32,000 Worth of Bulk Honey from Philadelphia Distribution Center
Agency acts after finding potent antibiotic in bulk honey
At the request of the Food and Drug Administration, federal marshals seized 64 drums of imported bee’s honey from a Philadelphia distribution center on June 4 because it contained a potent antibiotic that could lead to serious illness or death.
The seizure occurred at the Delaware Avenue Distribution Center, 700 Pattison Avenue, in Philadelphia. The bulk honey was imported by Sweet Works Inc., of Monterey Park, California from Cheng Du Wai Yuan Bee Products Company Limited of Chengdu, China. Subsequently, it was sold to Alfred L. Wolff Inc. of Chicago, which placed it in storage.
The FDA estimates the value of the seized goods to be more than $32,000. U.S. Marshals executed this seizure pursuant to a warrant issued by the U.S. District Court for the Eastern District of Pennsylvania. The honey is adulterated within the meaning of 21 U.S.C. 342(a)(2)(C) of the federal Food, Drug & Cosmetic Act, because it contains an unsafe food additive.
FDA testing of a sample of this product at the storage facility showed that it contained chloramphenicol, which is not approved for use in food, animal feed, or food-producing animals in the United States.
Chloramphenicol is a potent antibiotic drug that is approved only for use in humans with serious infections when other less toxic drugs won’t work. People who are sensitive to chloramphenicol can develop a type of bone marrow depression called aplastic anemia, which can be fatal.
"Unapproved food additives in the U.S. food supply are of significant concern to the agency,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA took this action because of the potential serious public health effects of this product.”
The FDA is now in the process of inventorying the seized goods.
This case is being investigated by FDA Philadelphia District with the assistance of the U.S. Marshals Service.
Consumer Inquiries: 888-INFO-FDA
FDA Seizes More Than $32,000 Worth of Bulk Honey from Philadelphia Distribution Center
Agency acts after finding potent antibiotic in bulk honey
At the request of the Food and Drug Administration, federal marshals seized 64 drums of imported bee’s honey from a Philadelphia distribution center on June 4 because it contained a potent antibiotic that could lead to serious illness or death.
The seizure occurred at the Delaware Avenue Distribution Center, 700 Pattison Avenue, in Philadelphia. The bulk honey was imported by Sweet Works Inc., of Monterey Park, California from Cheng Du Wai Yuan Bee Products Company Limited of Chengdu, China. Subsequently, it was sold to Alfred L. Wolff Inc. of Chicago, which placed it in storage.
The FDA estimates the value of the seized goods to be more than $32,000. U.S. Marshals executed this seizure pursuant to a warrant issued by the U.S. District Court for the Eastern District of Pennsylvania. The honey is adulterated within the meaning of 21 U.S.C. 342(a)(2)(C) of the federal Food, Drug & Cosmetic Act, because it contains an unsafe food additive.
FDA testing of a sample of this product at the storage facility showed that it contained chloramphenicol, which is not approved for use in food, animal feed, or food-producing animals in the United States.
Chloramphenicol is a potent antibiotic drug that is approved only for use in humans with serious infections when other less toxic drugs won’t work. People who are sensitive to chloramphenicol can develop a type of bone marrow depression called aplastic anemia, which can be fatal.
"Unapproved food additives in the U.S. food supply are of significant concern to the agency,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA took this action because of the potential serious public health effects of this product.”
The FDA is now in the process of inventorying the seized goods.
This case is being investigated by FDA Philadelphia District with the assistance of the U.S. Marshals Service.
Wednesday, June 9, 2010
Salmonellosis linked to Subway restaurants
Salmonellosis linked to Subway restaurants continues to plague the
state line with 2 cases now reported in Winnebago County. Those who
got sick ate at a Subway in Machesney Park. That now brings the total
to 60 cases of salmonellosis related to this outbreak in Illinois.
Normally this specific serotype is only seen in one or two cases a
year in the state.
http://www.promedmail.org/pls/apex/f?p=2400:1001:3307752478437061::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,83150
state line with 2 cases now reported in Winnebago County. Those who
got sick ate at a Subway in Machesney Park. That now brings the total
to 60 cases of salmonellosis related to this outbreak in Illinois.
Normally this specific serotype is only seen in one or two cases a
year in the state.
http://www.promedmail.org/pls/apex/f?p=2400:1001:3307752478437061::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,83150
Monday, June 7, 2010
FDA Takes Action Against California Soy-Product Manufacturer Lifesoy
Media Inquiries: Rita Chappelle, 301-796-4672 or 240-753-8603, rita.chappelle@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Takes Action Against California Soy-Product Manufacturer Lifesoy
Products made under conditions that violated federal law
Lifesoy Inc., a San Diego-based manufacturer of ready-to-eat soy products cited by the U.S. Food and Drug Administration for preparing, packing, and holding articles of food under insanitary conditions, has entered into a consent decree of permanent injunction in the U.S. District Court for the Southern District of California. The consent decree requires Lifesoy to stop manufacturing and distributing food products until the company registers with the FDA and complies with federal laws regarding sanitary practices.
Lifesoy made sweetened and unsweetened soy milk, fried tofu, fresh tofu, soybean pudding, and other soy products for human consumption. The government’s complaint further alleges that Lifesoy did not hold and store the foods under proper refrigeration conditions to prevent the growth of microorganisms.
U.S. District Judge Jeffrey T. Miller entered a consent decree of permanent injunction on June 2, 2010, against the company, and its owner, Long H. Lai. The consent decree permanently restrains and enjoins Lifesoy and Mr. Lai from directly or indirectly receiving, preparing, processing, packing, holding, and distributing any article of food, unless and until they come into compliance with the terms of the consent decree and the law.
“Today’s action shows that the FDA will seek enforcement action against companies that continue to violate federal laws designed to protect the safety of the nation’s food supply,” said FDA Acting Associate Commissioner for Regulatory Affairs Michael Chappell. “Food facilities such as Lifesoy are required by law to register with the FDA and follow current good manufacturing practices and other laws, including maintaining a sanitary facility.”
As part of the consent decree, Lifesoy must retain a qualified sanitation expert, with no personal or financial ties to the defendants, to develop and implement a written sanitation program to assure that the operations comply with current Good Manufacturing Practices. Before the company may reopen it must, among other things, receive FDA approval of its sanitation program and have the agency re-inspect the facility.
The government’s complaint alleged that Lifesoy and Mr. Lai caused articles of food to be adulterated under federal law by preparing, packing, and holding foods in such conditions that the products may be rendered injurious to health or may have become contaminated.
The complaint further alleged that Lifesoy did not hold and store the foods under proper refrigerated conditions to prevent the growth of microorganisms.
Lifesoy was first inspected by the FDA in November 2007. The Agency attempted to help the company come into compliance with appropriate food safety laws, however Lifesoy failed to comply resulting in this action.
Consumer Inquiries: 888-INFO-FDA
FDA Takes Action Against California Soy-Product Manufacturer Lifesoy
Products made under conditions that violated federal law
Lifesoy Inc., a San Diego-based manufacturer of ready-to-eat soy products cited by the U.S. Food and Drug Administration for preparing, packing, and holding articles of food under insanitary conditions, has entered into a consent decree of permanent injunction in the U.S. District Court for the Southern District of California. The consent decree requires Lifesoy to stop manufacturing and distributing food products until the company registers with the FDA and complies with federal laws regarding sanitary practices.
Lifesoy made sweetened and unsweetened soy milk, fried tofu, fresh tofu, soybean pudding, and other soy products for human consumption. The government’s complaint further alleges that Lifesoy did not hold and store the foods under proper refrigeration conditions to prevent the growth of microorganisms.
U.S. District Judge Jeffrey T. Miller entered a consent decree of permanent injunction on June 2, 2010, against the company, and its owner, Long H. Lai. The consent decree permanently restrains and enjoins Lifesoy and Mr. Lai from directly or indirectly receiving, preparing, processing, packing, holding, and distributing any article of food, unless and until they come into compliance with the terms of the consent decree and the law.
“Today’s action shows that the FDA will seek enforcement action against companies that continue to violate federal laws designed to protect the safety of the nation’s food supply,” said FDA Acting Associate Commissioner for Regulatory Affairs Michael Chappell. “Food facilities such as Lifesoy are required by law to register with the FDA and follow current good manufacturing practices and other laws, including maintaining a sanitary facility.”
As part of the consent decree, Lifesoy must retain a qualified sanitation expert, with no personal or financial ties to the defendants, to develop and implement a written sanitation program to assure that the operations comply with current Good Manufacturing Practices. Before the company may reopen it must, among other things, receive FDA approval of its sanitation program and have the agency re-inspect the facility.
The government’s complaint alleged that Lifesoy and Mr. Lai caused articles of food to be adulterated under federal law by preparing, packing, and holding foods in such conditions that the products may be rendered injurious to health or may have become contaminated.
The complaint further alleged that Lifesoy did not hold and store the foods under proper refrigerated conditions to prevent the growth of microorganisms.
Lifesoy was first inspected by the FDA in November 2007. The Agency attempted to help the company come into compliance with appropriate food safety laws, however Lifesoy failed to comply resulting in this action.
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