Thread: FDA RECALLS Aug. 2009 UPDATED DAILY

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Adams Extract & Spice, LLC Announces Recall Because of Possible Health Risk

Contact:
Jennifer Hawkes
1-888-672-1850 x208

FOR IMMEDIATE RELEASE -- August 07, 2009 -- Adams Extract and Spice, LLC. is announcing a voluntary recall of products because they have the potential to be contaminated with Salmonella. The products contain a specific lot of ground red pepper supplied by Van de Vries Spice Corporation, 9 Elkins Road, East Brunswick, New Jersey 08816 This lot of ground red pepper initially tested negative for salmonella. Subsequently, Adams Extract and Spice, LLC. has been informed that another sample drawn from the same lot has been confirmed positive for salmonella.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The following lots of specific products were distributed in Texas, Louisiana, and New Mexico through retail stores, mail order, internet sales and direct delivery.

The items listed below are in clear plastic (PET) bottles with yellow caps:

Adams Cayenne Pepper 2.61 oz Best by date 060311-060711, 062711-070111, 071811-072211, 080111-080511

Adams Brisket Rub 13.47 oz Best by date 062111-062511, 062711-070711

Adams Brisket Rub 8.5lbs Best by date 062811-070211

Adams Multi-Season Seasoned Salt 14.46 oz. Best by date 070511-070911

Adams Multi-Seasoning 30 oz. Best by date 071111-071511

REX Cayenne Pepper Ground 6.98 oz. Best by Date 072111-072511, 071111-071511

REX Cayenne Pepper 16 oz. Best by Date 071111-071511

The item listed below is in french square glass bottles with silver-tone caps:

Adams Reserve Cajun Seasoning 4.93oz. Best by date 061011-061711, 071311-071711

The items listed below are in translucent polypropylene jars with translucent caps:

Carniceria Texas Red All Purpose Seasoning Adams 14.25oz. Best by date 061711-062111

Carniceria B-B-Q Seasoning Adams 15.07oz. Best by date 061611-062011

The item listed below is in red trimmed "cello" packages:

REX Crab Boil Ready Mix 64 oz.

The item listed below is in green trimmed "cello" packages:

REX Fish Fry 10 oz.

No illnesses have been reported to date.

Consumers who have purchased these products are urged to return them to the place of purchase. Consumers with questions may contact:

Jennifer Hawkes at 1-888-672-1850 x208 8a-4:30p CST Monday-Friday or jhawkes@adamsffi.com.

Page Last Updated: 08/09/2009
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http://www.fda.gov/Safety/Recalls/ucm176343.htm

FDA warns drug companies selling unapproved narcotic pain meds

FDA warns drug companies like Glenmark Pharmaceuticals to stop making illegal meds.

Dallas, TX (JusticeNewsFlash.com)–
The United States Food and Drug Administration (FDA) www.fda.gov initiated another crack down on nine pharmaceutical manufacturing on Tuesday. Federal regulators issued warnings to drug makers, like Boehringer Ingelheim’s Roxane Inc unit, Covidien Ltd’s Mallinckrodt unit and Glenmark Pharmaceuticals, to stop selling 14 unapproved narcotic pain medications, as reported by Reuters.

The generic prescription drug companies must stop making unapproved versions of morphine, hydromorphone, and oxycodone within 60 days and stop all shipments within 90 days. The federal government’s health and law initiative wants to eliminate medications being sold to American consumers which have not been properly cleared and approved by the FDA. Mismanaged narcotic pain medications, and drugs with versions of the above generic formulas, have caused widespread injuries, illnesses, addictions, and even deaths across the nation.

By: Dallas Drug Injury Lawyer Amy K. Witherite - Amy Witherite. Eberstein & Witherite, LLP. 3100 Monticello Avenue, Suite 500. Dallas, TX 75205 - Toll Free: (888) 407-6669

Tags: american consumers, Dallas, drug injury lawyer, Drug Related Injuries, food and drug administration, hydromorphone, injury lawyer, oxycodone, pain

Written by Justice Seeker · Filed Under Drug Related Injuries, Justice News Flash
Online Drug Related Injuries Legal News Distribution - JusticeNewsFlash.com
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http://www.justicenewsflash.com/2009/04 ... 01997.html

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Liberté Yogourt Issues Allergy Alert on Undeclared Walnuts and Plums in Its Méditerranée Wild Blackberry Yogourt 6oz Product Distributed in the USA

Contact:
Roger Dickhout
CEO Liberté Brand Products
1-416-707-8761
1-905-458-3700

FOR IMMEDIATE RELEASE – St.Hubert Quebec,Canada - August 12, 2009 - Liberté Brand Products, St Hubert, Quebec, Canada announced that it is recalling all Liberté Méditerranée Wild Blackberry Yogourt 6 oz code dated Sept 02 distributed in the USA because it may contain undeclared walnuts and plums. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume the product.

Liberté Méditerranée Wild Blackberry yogourt was distributed nationwide. The product is packaged in a 6oz retail plastic container with the expiry code date of September 02 printed on the foil lid. The UPC Bar code is 0 65684 65434 5.

Liberte initiated the recall on August 11th 2009, when the company received an email from a consumer that found that containers labelled as Liberté Wild Blackberry yogourt actually contained the Liberté Méditerranée Plum and Walnut fruit preparation. Notwithstanding our internal quality safeguards, the Plum and Walnut filling was inadvertently put into the Wild Blackberry containers for some subset of this production run. The company has notified its distributors and retailers where the product was distributed and has asked that the products be removed from the shelves.

To date no illnesses have been reported from this product.

Consumers who have Liberté Méditerranée Wild BlackBerry Yogourt 6oz should destroy the product and contact Liberté at 1-888-340-9306 x 0 (Monday-Friday 8am-5pm EST) or via email at info@liberte.ca for a full refund.

The company is working cooperatively with the U.S. Food and Drug Administration until the recall is complete. We continue to evaluate the root cause of this problem and are making corrective actions.

We deeply regret the risk that this error has created for those who are allergic to the plum and walnut fruit preparation and the inconvenience that this recall has caused to our customers.

Page Last Updated: 08/12/2009
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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Limited Recall of 772 Cartons of Iced Jumbo Green Onions due to Possible Health Risk
Contact:
Lisa Largent
1-831-758-7810

FOR IMMEDIATE RELEASE - August 12, 2009, Salinas, CA - A precautionary voluntary recall of 772 cartons of iced jumbo green onions under the brand names Omo and Fu Choy distributed from three locations, R.A.M. Produce Distributors of Detroit, Michigan, Franzella Distributing of San Francisco, CA, and United Food Service of East Point, GA has been issued by California-based NewStar Fresh Foods due to the possible presence of Salmonella.

No illnesses have been reported. The product is packaged in a 48-count iced carton, item numbers 02487403 and 02487452, product lot numbers 40550707 and 40510707, with production dates of July 20th and July 21st 2009. No other food service distributors or products are involved in this recall.

All affected product within the foodservice channel has already been accounted for and destroyed.

58 cartons were shipped from two distributors to small grocery outlets in the Detroit and San Francisco areas. Consumers in California may have purchased the product from Larry’s Produce in Fairfield, La Loma Produce, Good Life Grocery and El Grande, all San Francisco, and Valley Produce & Meat Market, San Pablo. Consumers in Michigan may have purchased the product from Confers Supermarket in New Lothrop, Ryan’s Food in Detroit, Brothers Supermarket and Al Jazeera Market in Dearborn and Sahara Market in Warren.

Although it is likely that the jumbo green onions are now beyond their usable life, the recall is being issued by the company out of an abundance of caution for consumer well-being in the possible event some consumers might have purchased from the listed retail outlets and still have the product in their home refrigerators.

The company is working closely with regulatory authorities at the state and federal levels to inform consumers in Detroit and San Francisco areas who may have purchased the product.

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstance, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Customers who have purchased the jumbo green onions are urged to return it to the place of purchase for a full refund. Customers with questions may contact NewStar Fresh Foods at 1-831-758-7810.

Page Last Updated: 08/12/2009
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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Peregrina Cheese Corporation Recalls All Products Manufactured In Its Plant Because Of Possible Health Risk

Company Contact:
Customer Service
718-456-2391

FOR IMMEDIATE RELEASE – August 12, 2009 – Peregrina Cheese Corporation of Brooklyn, New York, is recalling all products manufactured in its Brooklyn, NY plant from March 17, 2009 to the present because they have 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.

This recall action is being conducted in accordance with the Consent Decree filed on July 20, 2009, which requires Peregrina Cheese Corporation to recall all products and codes produced in the Brooklyn plant from March 17, 2009 to the present.

The recall action involves the following products produced since March 17, 2009:


Peregrina Cheese brand QUESO FRESCO Fresh Cheese, 14 Oz. (397 g) foil-wrapped package, Plant # 36-8431, UPC 8 17424 00024 6, all lot codes on the market produced since March 17, 2009.
Chipilo brand MEXICAN CHEESE QUESO FRESCO – Fresh Cheese, NET WT. 15 oz. (425g), Plant #36-8431, UPC 8 17424 00028 4, all lot codes on the market produced since March 17, 2009.
Peregrina Cheese brand QUESO HEBRA Queso Oaxaca, NET WT. 15 Oz. (425g), Plant #36-8431, UPC 8 17424 00026 0, all lot codes on the market produced since March 17, 2009.
Peregrina Cheese brand QUESO COTIJA MOLIDO, NET WT. 15 OZ. plastic bags, Plant # 36-1388, UPC 8 17424 00027 7, all lot codes on the market produced since March 17, 2009.
Peregrina Cheese brand Flan, NET WT 8 oz., Plant # 36-8431, UPC 8 17424 00026 0, all lot codes on the market produced since March 17, 2009.
Peregrina Cheese brand GELATIN, NET WT. 10 OZ., Plant # 36-8431, UPC 8 17424 00031 4, all lot codes on the market produced since March 17, 2009.
Peregrina Cheese brand CREMA MEXICANA Mexican Cream, Weight 16 Oz., Plant # 55-8991, UPC 8 17424 00030 7, all lot codes on the market produced since March 17, 2009.
The products were distributed to retail stores in New York and Pennsylvania.

No illnesses have been reported to date.

This recall action is being conducted with the knowledge of the FDA.

Consumers who purchased the above listed products are urged not to consume them and to discard them immediately. Please direct questions regarding this recall action to Peregrina Cheese Corporation at 1-718-456-2391, Monday - Friday from 9 am - 4:30 pm EDT.

Page Last Updated: 08/13/2009
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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Barr Laboratories, Inc. issues a voluntary nationwide recall of Dextroamphetamine/Amphetamine 20mg Tablets, Lot number 311756

Contact:
Denise Bradley
215-591-8974

FOR IMMEDIATE RELEASE - August 13, 2009 - Barr Laboratories, Inc. is initiating a voluntary recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) 20mg Tablets, 100 count bottles, lot number 311756. The product identified is being recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets.

Potentially clinically significant adverse reactions to a supratherapeutic dose could include cardiovascular, neurologic, psychiatric and gastrointestinal reactions such as: palpitations, tachycardia, hypertension, headache, tremor, tic, dyskinesia, dizziness, blurred vision, sweating, insomnia, agitation, euphoria, mania, anxiety, restlessness, nausea, diarrhea, constipation, dry mouth, and decreased appetite.

This product can be uniquely identified as an oval peach colored tablet, debossed with b/973 on one side and 2/0 on the other side. Barr distributed the affected lot between 06/11/09 and 06/16/09. Only lot 311756 is affected by this recall.

Customers who have this lot in their possession are instructed to cease using the product and return it to their pharmacy/distributor. Wholesalers and retailers should cease distribution and examine their inventory immediately.

Consumers with questions may contact 888-742-5578 from 8:00am - 8:00pm EDT Monday-Friday.

Barr Laboratories has not received any adverse events for this product lot.

The FDA has been apprised of this action.

Any adverse reactions experienced with the use of this product should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http://www.fda.gov/Safety/MedWatch/default.htm.

Page Last Updated: 08/14/2009
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(NOT FDA RECALL)

Little Tikes recalls 1.6 million toy workshops and trucks

August 14, 2009 | 7:10 am

Little Tikes is recalling 1.6 million toy workshops and trucks after a toddler choked on a plastic nail.

The voluntary recall covers five toy models sold by Little Tikes as far back as March 1994, the Consumer Product Safety Commission said. The problem involves the bright red and blue plastic nails that accompanied the Hudson, Ohio-based company's Electronic Project Workshop, the Little Handiworker Workhorse, the Home Improvements Two-sided Workshop, the Swirlin' Sawdust Workshop and the Black Pickup Truck with Tools.

The toys were sold by major retailers including Toys R Us as well as online at www.littletikes.com and other websites for $25 to $100. Consumers should immediately take the toy nails away from young children and contact Little Tikes for a free replacement.

Little Tikes said in a statement that the toys were intended for children ages 2 and older. The child who swallowed the toy part was an 11-month-old boy from Goose Creek, S.C. The plastic nail -- about 3¼ inches long by 1¼ inch in diameter -- "forcefully lodged" in the boy's throat. He was hospitalized and has made a full recovery.

Some of the products are no longer sold by the company. But the toys may have been handed down to new owners or sold at garage sales.

Tom Richmond, general manager of Little Tikes Worldwide, said that"we realize Little Tikes toys are actively played with in homes where younger siblings reside and for that reason believe we must do everything possible to ensure the safety of not only the toddler or preschooler for whom the toy is intended, but also for other children who may come in contact with the toy.â€

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Hospira Issues Urgent Device Recall For AC Power Cords

Contact:
Stacey Eisen
(224) 212-2276

FOR IMMEDIATE RELEASE -- Lake Forest, Ill. -- August 14, 2009 -- Hospira, Inc. (NYSE: HSP), is initiating a nationwide recall of certain Hospira devices that have defective AC power cords manufactured by Electri-Cord Manufacturing Corporation. This recall is being issued in response to customer reports of sparking, charring and fires on the plug of the power cord. Hospira's investigation of these reports determined that the power cord's prongs may crack and fail at or inside the plug. The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires which may also occur in an oxygen-rich environment. Depending on the device and therapy, these failures may lead to potential serious injury or death. The products affected by this recall include:

LifeCare PCA Plus II Plum XL 3 Oximetrix 3 SO2/CO Cardiac Output Computer
LifeCare 5000 with DataPort Plum A+ v.10.3 Model 3300 Cardiac Output Computer
LifeCare PCA with Hospira MedNet Plum A+ Infusion System with Hospira MedNet Nutrimix Micro Compounder
LifeCare PCA 3 Plum A+3 v.11.3 Acclaim Encore Infusion Pump
LifeCare Model 4 infusion pump Plum LifeCare 5000 (Plum 1.6) with dataport GemStar AC Wall (Mains) Adapter (90-260 Volts-universal)
LifeCare 4200 PCA plus Infuser with Microgram delivery Plum A+3 GemStar Docking Station (90-260 Volts)
Plum XL3M Plum A+3 v.11.5 Optional Thermal Printer (For use with Model 3300 COC, Oximetrix 3 SO2/CO Computer, Q-Vue CCO Computer and Q2 CCO/SO2 Computer)
Plum XLM Plum A+3 Infusion System with Hospira MedNet Omniflow 4000 Plus
Plum XL Plum XL Infusion System Flexiflo Quantum Enteral Pump
Plum XLD Q2 Plus SO2/Continuous Cardiac Output Computer Q2 Continuous Cardiac Output (CCO)/SO2 Computer
Plum XL3M with Dataport Q2 CCO/SvO2 Monitoring System QVue CCO Monitoring System
Plum A+ Infusion System

Hospira will instruct users of these products to inspect and identify affected power cords on their infusion pumps, compounders, monitoring devices and printers to determine whether their product contains an affected Electri-Cord AC power cord.

Hospira is working with its customers to replace all affected power cords regardless of their condition. Hospira will begin service activity the week of Aug. 16, 2009, and will continue until all replacement activity is complete.

Users with affected power cords that have bent or cracked prongs, burnt plastic or excessive wear and tear should discontinue use immediately and contact their Hospira sales representative or Hospira Technical Support Operations at 1-800-241-4002 (available from 6 a.m. to 4 p.m., Pacific time) for instructions on receiving replacement parts or devices. Users with affected power cords that are not exhibiting any of these characteristics should monitor the power cords regularly and be mindful of excessive wear and tear, misuse or abuse until all affected cords can be replaced.

This recall is limited to device power cords with a prong and ground-pin insert design, which can be identified by a black plastic bridge connecting the terminal prongs on the plug (see Figure 1 below).

Figure 1: Affected Plug

Devices with power cords that do not have a black bridge connecting the terminal prongs on the plug are not affected (see Figure 2).

Figure 2: Not Affected Plug

Electri-Cord has identified the root cause of the issue and has implemented necessary design changes to reduce the likelihood of recurrence.

Hospira has not received any reports of serious patient harm related to the situation.

Hospira Technical Support Operations is available from 6 a.m. to 4 p.m. Pacific time Monday through Friday. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187 between 6 a.m. and 3 p.m. Pacific time.

Any adverse reactions experienced with the use of these products and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, 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.

About Hospira

Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellnessâ„¢. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Ill., and has more than 14,000 employees. Learn more at www.hospira.com.

Page Last Updated: 08/14/2009
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FDA issues warning on glucose test strips

WASHINGTON — The Food and Drug Administration has warned diabetes patients that certain blood sugar tests can give inaccurate results in patients taking other medications.

The FDA told consumers not to use certain glucose testing strips from Roche, Abbott Laboratories and other companies in combination with dialysis and other biologic drugs. The FDA stated those formulations can falsely elevate blood sugar results, raising the risk of insulin overdose.

Associated Press

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Shun Fung International Trading Inc. dba Yummy Foods Co.
is Conducting an URGENT Recall due to Undeclared Egg and Wheat in Wife Cake

Contacts:
Shun Fung International Inc.
DBA Yummy Foods Co.
2089 Ingalls Street
San Francisco, CA 94124
Tel: 415-822-1768

FOR IMMEDIATE RELEASE - August 14, 2009 - Yummy Foods Company of San Francisco, California, is recalling its 17 oz./480g Wife Cake because the product contains undeclared egg and wheat. People who have an allergy or severe sensitivity to egg or wheat run the risk of serious or life-threatening allergic reaction if they consume these products.

The product was distributed to individuals in California, Ranch 99 Supermarkets in Kent and Edmonds, Washington and Asian retail markets in California.

The product is sold in a pink box under the Yummy Foods Company brand name. There are 6 cakes to a box, 24 boxes to a case. This recall applies to all product having UPC 0 19151 00168 2.

No illnesses have been reported.

Customers or consumers who have this product are asked to please return the product to the Supermarket where it was purchased. Customers and consumers can reach Yummy Foods Company @ 415-822-1768 for product return instructions or questions. We can be reached between 8am-5pm Monday through Saturday, PDT.

Page Last Updated: 08/18/2009
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http://www.fda.gov/Safety/Recalls/ucm179279.htm