Source | CDC

CDC continues to receive reports from ophthalmologists that cases of Acanthamoeba keratitis, a potentially blinding infection, are occurring in the United States.

Multiple cases of infection caused by Acanthamoeba have occurred since May 26, 2007, the day the FDA announced the outbreak and the manufacturer issued a recall of the implicated multipurpose contact lens solution. The contact lens user in at least four of these cases continued to use AMO Complete® MoisturePlus™ multi-purpose contact lens solution and subsequently developed symptoms after the recall.

CDC has also learned during the interview stage of its investigation of the outbreak that many contact lens users do not know that AMO Complete® MoisturePlus™ multi-purpose contact lens solution has been recalled from the market because of its association with Acanthamoeba keratitis.

Healthy contact lens users from across the U.S. were interviewed by CDC as part of the ongoing investigation. They were asked if they had heard of a recalled contact lens solution and, if so, could they identify the name of that solution. Among the 151 people interviewed:

• 52.3% (79/151) were not aware of the recall
• Among those who were aware of the recall, only 26.8% (19/72) could correctly name the recalled product
• Of 15 people who reported using AMO Complete® MoisturePlus™ multi-purpose contact lens solution in April 2007, 80% (12/15) were still unaware of the recall and were still using the product

While FDA moved swiftly and worked with the manufacturer to enact this recall, millions of bottles of the solution, purchased prior to the recall, might still be in the homes of contact lens wearers. We are concerned that this lack of awareness among the general public — as well as eye care providers — is leading to continued use of the product by those who had purchased it prior to the recall. (It is often sold in bulk packaging at warehouse stores and bottles have a long expiration date).

Help is being sought to get the word out:

1. Check your medicine cabinet for AMO Complete® MoisturePlus™ multipurpose contact lens solution.
2. Stop using the product immediately and contact the company at 1-888-899-9183 or on the AMO Web site for instructions on what to do with unused solution;
3. Discard all soft contact lenses used with AMO Complete® MoisturePlus™;
4. Discard all contact lens storage cases used with AMO Complete® MoisturePlus™;
5. Consult your eye care provider about choosing an alternative contact lens solution;
6. Visit your eye care provider if you experience any signs of eye infection, including eye pain or redness, blurred vision, sensitivity to light, sensation of something in the eye, or excessive tearing and;
7. Visit CDC’s Acanthamoeba Web site for further instructions on contact lens use and other information.

Santa Ana, CA (PRWEB) July 30, 2007 — Four more products liability lawsuits were filed yesterday against the manufacturer of Complete® MoisturePlus™ contact lens solution in Orange County Superior Court in Santa Ana, California (Case #07CC01330, #07CC01331, #07CC01332, #07CC01333). The product was voluntarily recalled on May 25 at the request of the Food & Drug Administration in the wake of data collected and reviewed by the Centers for Disease Control linking the solution to a serious corneal infection known as Acanthamoeba keratitis. The new cases add to a growing number of injury and class action claims arising out of the recall.

Read Full Text: Schmidt & Clark Announces Multiple Lawsuits Filed Over Recalled Contact Lens Solution

Litigation against Advanced Medical Optics Continues to Expand as Company Moves to Re-Enter the Multipurpose Solution Business

SANTA ANA, Calif.–(BUSINESS WIRE)–Four more products liability lawsuits were filed yesterday against the manufacturer of Complete® MoisturePlus™ contact lens solution in Orange County Superior Court in Santa Ana, California (Case #07CC01330, #07CC01331, #07CC01332, #07CC01333). The product was voluntarily recalled on May 25 at the request of the Food & Drug Administration in the wake of data collected and reviewed by the Centers for Disease Control linking the solution to a serious corneal infection known as Acanthamoeba keratitis. The new cases add to a growing number of injury and class action claims arising out of the recall.

The lawsuits, naming vision products manufacturer Advanced Medical Optics, Inc., and its former parent company, Allergan, were brought by Dolores O. Morse, PhD (#07CC01332), and Kelly Segerstrom (#07CC01333), both Southern California residents, as well as Jacqueline Grossman (#07CC01331) and Krista Nelson (#07CC01330), who are residents of Washington. All of the plaintiffs allege that they contracted Acanthamoeba infections while they were using Complete® MoisturePlus™ to disinfect their contact lenses. The cases were filed by Newport Beach-based Moore Labriola LLP, which also filed the first post-recall lawsuit against AMO on June 4 (#07 CC 01296). The plaintiffs are also represented by Michael Schmidt of The Schmidt Firm and Schmidt & Clark, both based in Dallas.

Acanthamoeba infections can be chronic, resistant to treatment, and often require surgical interventions such as corneal transplantation. They not infrequently lead to blindness. Morse and Grossman both underwent surgical procedures as the result of infection-related damage and have lost the use of the affected eyes. Segerstrom is hopeful she has gotten through the worst of her infection thanks to intensive treatments, but still experiences vision problems. Nelson, a 16 year-old, continues to fight her infection, which was diagnosed last November. She is believed to be the first minor to file suit against AMO since the recall.

“We expect the litigation to grow significantly over the next several months,” said attorney Michael Schmidt, who added that his firm represents numerous Acanthamoeba victims from across the Country. Schmidt noted that many of the victims are minors. “AMO specifically targeted teenage contact lens wearers, like Krista, in their marketing campaigns,” said Schmidt, who noted that young people appear to be particularly susceptible to the risks of ineffective lens disinfectants.

According to the lawsuits, studies published well before the product was recalled showed the disinfectant in Complete® MoisturePlus™ was vastly inferior to hydrogen peroxide as well as other multipurpose contact lens solutions on the market in eradicating Acanthamoeba. The plaintiffs allege that AMO was aware of the ineffectiveness of their product but concealed that information from consumers.

The new lawsuits come a week after AMO announced plans to re-enter the multipurpose lens solution business. According to recent press reports, the company says it will start distributing an “older” formulation of the recalled product as early as August. The product will reportedly feature revised labeling designed to improve safety, and will instruct users to manually rub their lenses during the cleaning process. AMO had previously represented to consumers that they could effectively disinfect lenses without a rub step, a practice considered unsafe by many optometrists and ophthalmologists.

Attorney Thomas Moore says his clients are concerned that consumers may be misled by the launch of the old AMO formulation and may incorrectly presume the solution is adequately effective against Acanthamoeba. “The label changes are all well and good, but AMO continues to ignore the root problem, which is the ineffectiveness of their disinfectant ingredient under real-world conditions,” says Moore. The solution will reportedly use the preservative polyhexamethylene biguanide, which is the same disinfectant used in the recalled product. “That ingredient in concentrations routinely used by AMO and Allergan has been shown to be ineffective against Acanthamoeba in many published studies,” says Moore, who added that if AMO wants to take a leadership position in the contact lens solution industry, “they should develop a disinfectant that works, and stop blaming consumers for infections which could be prevented with effective products.”

Source | Baxter Healthcare Corp.

Models Include: COLLEAGUE Volumetric Infusion pump 2M8151 and 2M8153; COLLEAGUE CX Volumetric Infusion pump 2M8161 and 2M8163;  FLO-GARD Volumetric Infusion pump 2M8063 and 2M8064

DEERFIELD, Ill., July 25, 2007 – Baxter Healthcare Corporation today announced that the U.S. Food and Drug Administration (FDA) has classified Baxter’s voluntary recall action regarding falsification of service and repair data for the COLLEAGUE and FLO-GARD infusion pumps as a Class I recall. The recall pertained to 534 infusion pump devices in the U.S. brought in for routine maintenance or corrections at the company’s Phoenix, Arizona service center.

“In the course of its ongoing quality control processes, the company discovered falsified repair, test and inspection data sheets, which included electrical safety data.”

Therefore, it is possible that pumps sent to be serviced, repaired or corrected were returned without service being performed on them. Three employees in the Phoenix service center associated with this matter have been dismissed. The company has recalled affected devices and has informed all customers to contact Baxter and return the pumps for repeat inspection. All affected customers have been notified and no serious injuries or patient deaths have been associated with this action to date. This recall action impacts only pumps distributed in the United States.

This action has been classified by FDA as a Class I recall 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 Volumetric Infusion pump 2M8063 and 2M8064; COLLEAGUE Volumetric Infusion pump 2M8151 and 2M8153; and COLLEAGUE CX Volumetric Infusion pump 2M8161 and 2M8163.

Source | FDA

Date Recall:  Initiated June 21, 2007
 
Product: Baxter Colleague® and FLO-GARD® Volumetric Infusion Pumps

• COLLEAGUE® Volumetric Infusion Pump (2M8151, 2M8153)
• COLLEAGUE® CX Volumetric Infusion Pump (2M8161, 2M8163)
• FLO-GARD® Volumetric Infusion Pump (2M8063, 2M8064)

From April, 2006 through February, 2007, Baxter distributed 534 pumps to 170 customers (including distributors, medical facilities, retail companies and one institution) within the U.S.

Use: Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.
 
Recalling Firm: Baxter Healthcare Corp., Rt. 120 & Wilson Rd., Round Lake, Illinois 60073 

Reason for Recall: The firm identified repair, inspection & test data sheets, which included electrical safety data, for the pumps, that were falsified.

FDA Comments: On June 21, 2007, Baxter contacted their customers informing them that the company discovered, during ongoing quality control processes, that repair, test and inspection data sheets, including electrical safety data, were falsified. As a result, it may be possible that pumps sent to be serviced, repaired, or corrected were returned without service being performed on them. This 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 that can result in death.

The company requested their customers to locate the affected pumps and take them out of service as soon as possible, and send them back to Baxter for repeat inspections and servicing. Baxter will provide loaner pumps to customers that require them, free of charge.

For more information about this recall, please see the company’s press release at:

http://www.baxter.com/about_baxter/news_room/news_releases/2007/07-25-07-service_documentation.html

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

See also: June 20, 2007, Recall for Baxter Upgraded COLLEAGUE® Triple Channel Volumetric Infusion Pumps
http://www.fda.gov/cdrh/recalls/recall-062007.html

Source | FDA

Date Recall:  Initiated June 8, 2007
 
Product: Thoratec® TLC-II® Portable Ventricular Assist Device (VAD) Driver, Catalog Number 20010-0000-032.

From September 1, 2005 through June 4, 2007, Thoratec® distributed 378 VAD units to 378 hospitals (251 within the U.S and 127 outside the U.S.).
 
Use: A ventricular assist device is a mechanical pump that helps a person’s heart that is too weak to pump blood through the body. The VAD is designed to provide sufficient blood flow to the damaged or diseased heart. It is sometimes referred to as a “bridge to transplant” since it can help a patient survive until a heart transplant can be performed.
 
Recalling Firm: Thoratec® Corporation, 6035 Stoneridge Drive, Pleasanton, California 94588

Reason for Recall: VAD support for the patient’s circulatory system may fail. The VAD driver may stop due to earlier than expected wear-out of the compressor motor (much less than the expected 3000 hours). The compressor motor can stop without warning. When the motor fails, there is a loss of VAD support for the patient. This results in inadequate blood flow to and from the heart. 

FDA Comments: Thoratec® notified most hospitals (77% acknowledgement) regarding servicing of their current inventory of the TLC-II Portable VAD Drivers. The hospitals must:

• check the current number of service hours on all units
• not use the TLC-II® drivers exceeding 1500 hours until they are serviced by Thoratec®
• note the indicated number of hours on the product inventory form and return the form to Thoratec®
• ensure that all patients have a back up driver and hand pumps at all times and have been trained in backup procedures.

Thoratec® has arranged for the return and servicing of all affected drivers, with the highest priority to those drivers already exceeding 1500 hours. There is a risk of the driver to fail between 1500 and 3000 hours.

When the 1500 hour limit has been reached, patients must stop using the device and then send it to the manufacturer for servicing. Patients should replace all drivers at 1500 hours and go back to the hospital for a new backup replacement.

A patient must have a back-up or hand pump in their possession at all times. If the switch does not take place fast enough (within a minute), the patient may suffer a stroke or brain damage.

Patients just receiving these units should inquire when the alarm will notify them of the need for servicing. If the driver is programmed to alarm at 3000 hours, then be sure to change the driver to the backup replacement unit at 1500 hours and obtain a new backup replacement driver.

Doctors should be contacting their patients about this device. If patients have any questions, they should contact their doctor.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Online: www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
FAX: 1-800-FDA-0178

Do I have a Thoratec VAD or PVAD Lawsuit?

If you or a loved one have been injured or killed by a Thoratec cardiac device, you should contact us immediately. You may be entitled to compensation and we can help.

Source | FDA

Date Recall:  Initiated March 30, 2007
 
Product: Thoratec® Paracorporeal Ventricular Assist System, (PVAD) Model TLC-II®, Catalog No. 14086-2550-000, manufactured from January 1, 2004 through October 2, 2006, and with expiration dates of January, 2007 to October, 2009.

From January 2, 2004 through February 23, 2007, 2484 units were distributed to 146 customers (distributors, hospitals and medical centers), 123 customers within the U.S. and to 23 customers outside the U.S. PVADs with serial numbers 10745 or less were shipped after January, 2004.
 
Use: The PVAD is a part of the Vascular Assist Device. A ventricular assist device is a mechanical pump that helps a person’s heart that is too weak to pump blood through the body. The VAD is designed to provide sufficient blood flow to the damaged or diseased heart. It is sometimes referred to as a “bridge to transplant” since it can help a patient survive until a heart transplant can be performed. The device is also used for patients who are recovering from heart surgery and must continue on a heart-lung machine.
 
Recalling Firm: Thoratec® Corporation, 6035 Stoneridge Drive, Pleasanton, California 94588

Reason for Recall: The PVAD may contain a black collet (circular rim) that holds a rod-like piece in place (nut). This black collet and nut was intended to be used with a cannula (a small tube) of an older design that had a larger diameter. If this black collet and nut is used with the current design of cannula that has a smaller diameter, it can disconnect during use. The blood is pumped from the VAD through the cannula into the patient. (The black collet is similar to how a washer works with a nut. It is called a black collet because the collet and matching nut are painted black for easy identification). 

FDA Comments: The company has issued an “urgent medical device correction” notice to all VAD customers alerting them about the problem. The letter instructs customers that a Thoratec® representative will be contacting them to make arrangements to apply a warning label to the affected devices. The letter also informs the customers to dispose of any expired original design cannula and:

• not use the black collet and nut with any design VAD
• make sure that all current patients using PVADs are using the white collet nut that is packaged with the cannula
• provide a copy of the product safety bulletin to all hospitals and/or physicians that may be following patients implanted with PVADs, and
• provide contact information with the acknowledgement form  

Once the company calls the hospitals and/or medical centers, it is up to the individual doctors to contact their patients.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Online: www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
FAX: 1-800-FDA-0178

Do I have a Thoratec PVAD or VAD Lawsuit?

If you or a loved one have been injured or killed by a Thoratec cardiac device, you should contact us immediately. You may be entitled to compensation and we can help.

The following products are subject to recall: 

• 12-pack of 15-ounce cans of “Austex Beef Stew.”
• 15- and 19-ounce cans of “Austex Chili with Beans.”
• 12-pack of 15-ounce cans of “Austex Chili No Beans.”
• 12-pack of 19-ounce cans of “Austex Chili No Beans.”
• 15-ounce cans of “Best Yet Chili with Beans.”
• 15-ounce cans of “Best Yet Corned Beef Hash.”
• 15-ounce cans of “Big Y Chili with Beans.”
• 15-ounce cans of “Big Y Chili no Beans.”
• 15-ounce cans of “Big Y Corned Beef Hash.”
• 15-ounce cans of “Black Rock Chili with Beans.”
• 24-pack of 10-ounce cans of “Bryan Hot Dog Chili Sauce.”
• 24-pack of 15-ounce cans of “Bryan Corned Beef Hash.”
• 24-pack of 10-ounce cans of “Bryan Chili No Beans.”
• 24-pack of 15-ounce cans of “Bryan Chili No Beans.”
• 24-pack of 15-ounce cans of “Bryan Chili with Beans.”
• 10-ounce cans of “Bunker Hill Chili no Beans.”
• 10-ounce cans of “Bunker Hill Chunky Chili no Beans.”
• 10-ounce cans of “Castle Chili No Beans.”
• 15-ounce cans of “Castleberry’s Beef Stew.”
• 15-ounce cans of “Castleberry’s Brunswick Stew.”
• 10-ounce cans of “Castleberry’s BUNKER HILL, ORIGINAL Chili NO BEANS.”
• 15-ounce cans of “Castleberry’s CHILI WITH BEANS.”
• 12-pack of 15-ounce cans of “Castleberry’s Chili No Beans.”
• 15-ounce cans of “Castleberry’s Corned Beef Hash.”
• 10-ounce cans of “Castleberry’s HICKORY SMOKED, OVEN ROASTED, WITH SKINS, BARBECUE PORK IN BARBECUE SAUCE.”
• 12-pack of 15-ounce cans of “Castleberry’s Hot Chili with Beans.”
• 10- and 14.5-ounce cans of “Castleberry’s BBQ Pork.”
• 10-ounce cans of “Castleberry’s Sausage Gravy.”
• 10-ounce cans of “Castleberry’s Chip Beef Gravy.”
• 15-ounce cans of “Cattle Drive Beef Stew.”
• 15-ounce cans of “Cattle Drive Chili with Beans.”
• 15-ounce cans of “Cattle Drive Chili no Beans.”
• 15-ounce cans of “Cattle Drive CHILI WITH BEANS.”
• 8-pack of 15-ounce cans of “Cattle Drive Chili with Beans.”
• 15-ounce cans of “Cattle Drive Chicken Chili with Beans.”
• 15-ounce cans of “Firefighter Chicken Chili.”
• 15-ounce cans of “Firefighter Chicken Chili with Beans.”
• 15-ounce cans of “Firefighter Chili with Beans.”
• 15-ounce cans of “Firefighter Chili no Beans.”
• 15-ounce cans of “Food Club Chili with Beans.”
• 15-ounce cans of “Food Club Corned Beef Hash.”
• 15-ounce cans of “Georgia Hash.”
• 10- and 15-ounce cans of “Goldstar Chili.”
• 15-ounce cans of “Goldstar Tex Mex Chili.”
• 15-ounce cans of “Great Value Chili with Beans.”
• 15-ounce cans of “Great Value Hot Chili with Beans.”
• 15-ounce cans of “Kroger Beef Stew.”
• 15-ounce cans of “Kroger Chili with Beans.”
• 15-ounce cans of “Kroger Chili no Bean.”
• 15-ounce cans of “Lowes Chili no Bean.”
• 15-ounce cans of “Lowes Chili with Beans.”
• 15-ounce cans of “Lowes Corn Beef Hash.”
• 15-ounce cans of “Meijer Chili with Beans.”
• 15-ounce cans of “Meijer Chili no Beans.”
• 15-ounce cans of “Meijer CORNED BEEF HASH.”
• 12-pack of 15-ounce cans of “Morton House Chili with Beans.”
• 15-ounce cans of “Morton House Corned Beef Hash.”
• 10- and 15-ounce cans of “Paramount Hot Dog Chili Sauce.”
• 15-ounce cans of “Paramount Chili no Bean.”
• 15-ounce cans of “Paramount Chili with Beans.”
• 15-ounce cans of “Piggly Wiggly Chili with Beans.”
• 10- and 15-ounce cans of “Piggly Wiggly Chili no Bean.”
• 15-ounce cans of “Piggly Wiggly Corned Beef Hash.”
• 12-pack of 15-ounce cans of “Prudence Corned Beef Hash.”
• 15-ounce cans of “Southern Home Chili with Beans.”
• 10- and 15-ounce cans of “Southern Home Chili no Bean.”
• 15-ounce cans of “Southern Home Corned Beef Hash.”
• 10-ounce cans of “Steak N Shake Chili.”
• 15-ounce cans of “Thrifty Maid Chili with Beans.”
• 15-ounce cans of “Thrifty Maid Corned Beef Hash.”
• 15-ounce cans of “Triple Bar Chili with Beans.”
• 12-pack of 15-ounce cans of “Triple Bar Chili with Beans.”
• 15-ounce cans of “Triple Bar Chili no Beans.”
• 12-pack of 15-ounce cans of “Triple Bar Chili no Beans.”
• 15-ounce cans of “Value Time Chili with Beans.”

Source | USDA

WASHINGTON, July 21, 2007 - Castleberry’s Food Company, an Augusta, Ga., establishment owned by Bumble Bee Foods, LLC, is voluntarily expanding its July 19 recall of canned meat products that may contain Clostridium botulinum, the U.S. Department of Agriculture’s Food Safety and Inspection Service announced today.

The recall is being expanded after information gathered by the Food and Drug Administration (FDA) and FSIS indicated that processing malfunctions at the establishment have existed longer than initially estimated. For that reason, Castleberry’s has agreed to recall all of the following products that may still be in commerce, regardless of the “best buy” date stamped on the bottom of the can. Consumers who have any of the products listed are urged not to eat them, but rather return or dispose of them.

The following products are subject to recall:

• 12-pack of 15-ounce cans of “Austex Beef Stew.”
• 15- and 19-ounce cans of “Austex Chili with Beans.”
• 12-pack of 15-ounce cans of “Austex Chili No Beans.”
• 12-pack of 19-ounce cans of “Austex Chili No Beans.”
• 15-ounce cans of “Best Yet Chili with Beans.”
• 15-ounce cans of “Best Yet Corned Beef Hash.”
• 15-ounce cans of “Big Y Chili with Beans.”
• 15-ounce cans of “Big Y Chili no Beans.”
• 15-ounce cans of “Big Y Corned Beef Hash.”
• 15-ounce cans of “Black Rock Chili with Beans.”
• 24-pack of 10-ounce cans of “Bryan Hot Dog Chili Sauce.”
• 24-pack of 15-ounce cans of “Bryan Corned Beef Hash.”
• 24-pack of 10-ounce cans of “Bryan Chili No Beans.”
• 24-pack of 15-ounce cans of “Bryan Chili No Beans.”
• 24-pack of 15-ounce cans of “Bryan Chili with Beans.”
• 10-ounce cans of “Bunker Hill Chili no Beans.”
• 10-ounce cans of “Bunker Hill Chunky Chili no Beans.”
• 10-ounce cans of “Castle Chili No Beans.”
• 15-ounce cans of “Castleberry’s Beef Stew.”
• 15-ounce cans of “Castleberry’s Brunswick Stew.”
• 10-ounce cans of “Castleberry’s BUNKER HILL, ORIGINAL Chili NO BEANS.”
• 15-ounce cans of “Castleberry’s CHILI WITH BEANS.”
• 12-pack of 15-ounce cans of “Castleberry’s Chili No Beans.”
• 15-ounce cans of “Castleberry’s Corned Beef Hash.”
• 10-ounce cans of “Castleberry’s HICKORY SMOKED, OVEN ROASTED, WITH SKINS, BARBECUE PORK IN BARBECUE SAUCE.”
• 12-pack of 15-ounce cans of “Castleberry’s Hot Chili with Beans.”
• 10- and 14.5-ounce cans of “Castleberry’s BBQ Pork.”
• 10-ounce cans of “Castleberry’s Sausage Gravy.”
• 10-ounce cans of “Castleberry’s Chip Beef Gravy.”
• 15-ounce cans of “Cattle Drive Beef Stew.”
• 15-ounce cans of “Cattle Drive Chili with Beans.”
• 15-ounce cans of “Cattle Drive Chili no Beans.”
• 15-ounce cans of “Cattle Drive CHILI WITH BEANS.”
• 8-pack of 15-ounce cans of “Cattle Drive Chili with Beans.”
• 15-ounce cans of “Cattle Drive Chicken Chili with Beans.”
• 15-ounce cans of “Firefighter Chicken Chili.”
• 15-ounce cans of “Firefighter Chicken Chili with Beans.”
• 15-ounce cans of “Firefighter Chili with Beans.”
• 15-ounce cans of “Firefighter Chili no Beans.”
• 15-ounce cans of “Food Club Chili with Beans.”
• 15-ounce cans of “Food Club Corned Beef Hash.”
• 15-ounce cans of “Georgia Hash.”
• 10- and 15-ounce cans of “Goldstar Chili.”
• 15-ounce cans of “Goldstar Tex Mex Chili.”
• 15-ounce cans of “Great Value Chili with Beans.”
• 15-ounce cans of “Great Value Hot Chili with Beans.”
• 15-ounce cans of “Kroger Beef Stew.”
• 15-ounce cans of “Kroger Chili with Beans.”
• 15-ounce cans of “Kroger Chili no Bean.”
• 15-ounce cans of “Lowes Chili no Bean.”
• 15-ounce cans of “Lowes Chili with Beans.”
• 15-ounce cans of “Lowes Corn Beef Hash.”
• 15-ounce cans of “Meijer Chili with Beans.”
• 15-ounce cans of “Meijer Chili no Beans.”
• 15-ounce cans of “Meijer CORNED BEEF HASH.”
• 12-pack of 15-ounce cans of “Morton House Chili with Beans.”
• 15-ounce cans of “Morton House Corned Beef Hash.”
• 10- and 15-ounce cans of “Paramount Hot Dog Chili Sauce.”
• 15-ounce cans of “Paramount Chili no Bean.”
• 15-ounce cans of “Paramount Chili with Beans.”
• 15-ounce cans of “Piggly Wiggly Chili with Beans.”
• 10- and 15-ounce cans of “Piggly Wiggly Chili no Bean.”
• 15-ounce cans of “Piggly Wiggly Corned Beef Hash.”
• 12-pack of 15-ounce cans of “Prudence Corned Beef Hash.”
• 15-ounce cans of “Southern Home Chili with Beans.”
• 10- and 15-ounce cans of “Southern Home Chili no Bean.”
• 15-ounce cans of “Southern Home Corned Beef Hash.”
• 10-ounce cans of “Steak N Shake Chili.”
• 15-ounce cans of “Thrifty Maid Chili with Beans.”
• 15-ounce cans of “Thrifty Maid Corned Beef Hash.”
• 15-ounce cans of “Triple Bar Chili with Beans.”
• 12-pack of 15-ounce cans of “Triple Bar Chili with Beans.”
• 15-ounce cans of “Triple Bar Chili no Beans.”
• 12-pack of 15-ounce cans of “Triple Bar Chili no Beans.”
• 15-ounce cans of “Value Time Chili with Beans.”

Each can label or can end bears the establishment number “EST. 195″ inside the USDA seal of inspection. The canned meat products were distributed nationwide. The problem was discovered during an investigation into illnesses in Indiana and Texas. The investigation led to a recall by FDA of three types of meatless hotdog chili sauce. The FDA’s recall release can be found at www.fda.gov. That recall is also being expanded to include all meatless products produced at the plant that might still be in commerce. There have been no reports of illness from consumption of the products listed in this news release.

Botulism is a rare but serious paralytic illness caused by a nerve toxin. Symptoms of botulism include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth, and muscle weakness. The illness can cause paralysis, respiratory failure and death. Symptoms usually occur from 18 to 36 hours after eating contaminated food. Anyone who is experiencing any of these symptoms should contact a physician. For additional information about botulism, please visit the Centers for Disease Control and Prevention’s Web site at www.cdc.gov/botulism/botulism.htm.

Source | FDA

The U.S. Food and Drug Administration is expanding its July 18 warning to consumers. This expansion is for consumers and pet owners regarding canned food products and dog food produced by Castleberry’s Food Company of Augusta, Ga., due to the risk of botulinum toxin. Castleberry’s is expanding the recall to include all of the following canned products with all “best by” and code dates, and FDA is warning consumers not to purchase or eat any of the canned products listed in the table below.

The agency is expanding its warning based in part on FDA test results and information obtained during a joint FDA and U.S. Department of Agriculture inspection of the Castleberry’s facility in Augusta, Ga.

Exposure to botulinum toxin can be fatal and two people in Texas and two people in Indiana remain seriously ill and hospitalized with botulism poisoning associated with eating Castleberry’s Hot Dog Chili Sauce.

While the previous recall and the known illnesses are linked to “best by” dates of April 30 to May 22, 2009, the firm has extended the recall to include all products listed irrespective of “best by” date. The firm is cooperating with FDA in the recall of these products and has ceased processing and distribution.

In addition, Castleberry’s is recalling other products containing meat, which are regulated by the U.S. Department of Agriculture. USDA is also warning the public not to eat certain brands of Castleberry’s products containing meat. The list of these USDA-regulated products can be viewed at this link to the USDA website: http://www.fsis.usda.gov/News_&_Events/Recall_033_2007_expanded/index.asp

Consumers who have any of these products or any foods made with these products should throw them away immediately. Double bag the cans in plastic bags that are tightly closed then place in a trash receptacle for non-recyclable trash outside of the home. Additional instructions for safe disposal can be found at www.cdc.gov/botulism/botulism_faq.htm

Retailers that have any of these products are asked to assure that they are removed from use and do not accidentally get reintroduced for sale, service or donation.

Symptoms of botulism poisoning in humans can begin from 6 hours to 2 weeks after eating food that contains the toxin. Symptoms may include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, and muscle weakness that moves progressively down the body, affecting the shoulders first then descending to the upper arms, lower arms, thighs, calves, etc. Botulism poisoning can also 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 one of the Castleberry’s products currently under recall should seek immediate medical attention.

The disease has only been seen occasionally in dogs and has not been reported in cats. Ferrets are highly susceptible to botulinum toxin. The incubation period can be 2 hours to 2 weeks; in most cases, the symptoms appear after 12 to 24 hours. Botulism is characterized by progressive motor paralysis. Typical clinical signs may include muscle paralysis, difficulty breathing, chewing and swallowing, visual disturbances and generalized weakness may also occur. Death usually results from paralysis of the respiratory or cardiac muscles. Pet owners who have used these products and whose pets have these symptoms should contact their veterinarian immediately. At this time we are not aware of pet illnesses associated with these products although we recommend that all these products should be discarded.