Author: Phyllis Entis

Taco Bell Named In Multi-State Salmonella Outbreak

On January 19th, the US CDC reported a multi-state outbreak of 68 confirmed cases of Salmonella enteritidis gastroenteritis associated with eating food from “Restaurant A,” which the Investigation Announcement described as a Mexican-style fast food restaurant chain. Forty-three of the confirmed cases were reported by Texas, and 16 by Oklahoma. Outbreak illnesses also were reported by Kansas (2), Iowa (1), Michigan (1), Missouri (1), Nebraska (1), New Mexico (1), Ohio (1), and Tennessee (1).

Ever since the Investigation Announcement was released, CDC has ignored, dodged, and declined to answer repeated requests from the media – including an Open Letter published on eFoodAlert – to identify Restaurant A. In a recent interview with JoNel Aleccia of MSNBC, Dr. Robert Tauxe, CDC’s deputy director of the Division of Foodborne, Waterborne and Environmental Diseases, explained the agency’s policy.

“The longstanding policy,” Tauxe told Aleccia, “is we publicly identify a company only when people can use that information to take specific action to protect their health. On the other hand,” he added, “if there’s not an important public health reason to use the name publicly, CDC doesn’t use the name publicly.”

Fortunately, the state of Oklahoma takes a broader view than CDC of the public’s right to know the identity of Restaurant A.

I have just learned, courtesy of the Oklahoma State Department of Health Acute Disease Service, that “Restaurant A” is Taco Bell. Following is the summary I was given of Oklahoma’s participation in the outbreak investigation.

Oklahoma State Department of Health
Acute Disease Service 

Summary of Supplemental Questionnaire Responses Specific to
Taco Bell Exposure of Oklahoma Outbreak-associated Cases
Multistate Salmonella Enteritidis Outbreak Investigation
November 2011 – January 2012 

Summary Demographic information

  • 16 cases in 5 Oklahoma counties
    • Cleveland (10), Bryan (2), Lincoln (2), Pottawatomie (1), and Greer (1)
  • Onset date range: 10/21/2011 – 11/18/2011
    • 1 onset date unknown but believes around Thanksgiving
  • Hospitalizations: 4
  • Gender distribution: 10 (63%) females and 6 (37%) males
  • Age range: 5 to 78 years (median 23 years)

Taco Bell exposure summary of Oklahoma cases from supplemental case-control questionnaire responses

  • Total Oklahoma cases: 16
  • Total interviewed: 12/16 (4 refused or were lost-to-follow-up)
  • Consumed food from Taco Bell: 8/11

CDC  reported that it was unsuccessful in determining the food source for this outbreak; however, the agency took pains to add that ground beef was an unlikely source, due to the restaurant chain’s handling and cooking processes. Patrons of the Taco Bell chain can draw some comfort from CDC’s assessment that its outlets follow appropriate handling and cooking procedures for raw ground beef.

Perhaps now that the Salmonella Enteritidis has hit the fan, CDC will deign to confirm the identity of the mysterious Restaurant A.

Recalls and Alerts: January 31, 2012

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

United States

  • Allergy Alert: Gemini Food Corporation (City of Industry, CA) and Tong Enterprises (Hayward, CA) recall Bin-Bin Snow Rice Crackers (5.3 oz/150; all codes) and Bin-Bin Rice Crackers (15.8oz/450g; all codes) due to the presence of undeclared eggs. The recalled product was distributed nationwide.
  • Pediatric Medical Food Safety Recall: Vitaflo USA recalls Renastart (14.11-oz/400g cans; Batch No. 12832), because some of the product shipped throughout the USA from December 29, 2011 through January 26, 2012 has been incorrectly labeled. Renostart is a powdered medical food used in the dietary management of pediatric renal disease, for patients one year and older in the United States. The company urges all patients (or their caregivers) “…who have consumed any Renastart from this batch should contact their health care professional immediately to determine next steps, including nutritional management alternatives.”
  • Food Safety Recall: The Kroger Company recalls Deli Country Potato Salad, RW and Bakers Country Potato Salad, 5-lb because the products may be contaminated with Listeria monocytogenes. The recalled potato salads were sold in Dillons, Baker’s, Gerbes and Food4Less Fremont stores.
  • Food Safety Recall: Super1Foods & Discount Pharmacy recalls Deli Fresh Gourmet Mustard Potato Salad (3 lb; Batch 3/19/12), because the potato salad contains hard-cooked eggs recalled by Michael Foods due to possible contamination with Listeria monocytogenes.
  • Food Safety Recall: Brookshire’s food & pharmacy recalls Brookshire’s brand Southern Mustard Potato Salad (1 lb and 3 lb; Batch 3/19/12), and Deli Fresh Gourmet Mustard Potato Salad (3 lb; Batch 3/12/12), because the potato salad contains hard-cooked eggs recalled by Michael Foods due to possible contamination with Listeria monocytogenes.
  • Food Withdrawal: Topco Associates withdraws Spartan Pasteurized Processed Cheese Food Individually Wrapped Slices (3-lb; Date code April 3, 2012; Manufactured by Great Lakes Cheese), because the cheese slices cannot be peeled cleanly from the wrapper. This is NOT a food safety issue. The withdrawn product was sold through the Spartan family of stores, including VG’s grocery, Spartan, Valu Land, VG’s Fresh Market, Glen’s Markets, Glen’s Fresh Market, Family Fare Supermarkets, and D&W Fresh Market.
  • FDA Enforcement Action: FDA has asked a U.S. District Court to issue a permanent injunction agains Mexicali Cheese (Woodhaven, NY) and two of its officers, because the firm has a history of unsanitary conditions and of producing cheese in a facility that is contaminated with Listeria monocytogenes. Mexicali Cheese manufactures and distributes soft Mexican cheeses to grocery stores and supermarkets in New York, New Jersey and Connecticut.
  • FDA Warning Letter: FDA warns Douty Brothers, Inc. (Portland, ME) that a December 2011 inspection of the company’s seafood processing facility revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, and the Current Good Manufacturing Practice regulation for foods.
  • FDA Warning Letter: FDA warns Negocios Industriales Real “N.I.R.S.A.”, S.A. (Guayaquil, Ecuador) that an August 2011 inspection of the company’s seafood processing facility revealed serious deviations from the seafood Hazard Analysis and Critical Control Point regulation.
  • FDA Warning Letter: FDA warns Flavors from Florida, Inc. (Bartow, FL) that a September 2011 inspection of the company’s juice processing facility revealed inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for food.
  • FDA Warning Letter: FDA warns Pacific Cheese Company, Inc. (Hayward, CA) that a follow-up inspection conducted during February-March 2011 of the company’s cheese processing facility revealed the presence of Listeria monocytogenes in samples of cubed and shredded cheddar cheese collected from a third-party warehouse. In addition, FDA found the company’s response to the agency’s FDA Form 483-Inspectional Observations to be inadequate.
  • Outbreak Alert Update: The outbreak of Campylobacter illnesses in Pennsylvania and Maryland believed to be associated with the consumption of raw milk from The Family Cow farm in Pennsylvania has grown to 12 cases.
  • Outbreak Alert: Health officials in Louisville, Kentucky report an unusually high number of cases of shigellosis. There have been 84 lab-confirmed cases in the last 13 weeks, including 18 cases during the week of January 23rd. The metropolitan area has averaged just 62 confirmed cases per year over the past five years. Shigellosis is a highly contagious diarrhea caused by Shigella bacteria.
  • Outbreak Alert Update: The outbreak of Norovirus gastroenteritis linked to the Harbor Inn Seafood restaurant in Conover, NC has grown to 128 complaints. Most of the victims report having eaten at the restaurant on January 13th or 14th.
  • Outbreak Alert: Norovirus has been fingered as the probable cause of an outbreak of gastroenteritis at the Lytton Gardens senior living center in downtown Palo Alto, CA. The illnesses have affected 10 residents and 2 staff members between January 5th and 18th.

Canada

  • Allergy Alert: The Canadian Food Inspection Agency warns the individuals who are allergic to egg not to consume the following Bin Bin Rice Crackers, which have been recalled by the importers because the products contain undeclared egg: Snow Rice Crackers (150g; UPC 8 852098 700124), Rice Crackers Jumbo Bag (450g; UPC 8 852098 701510), and Rice Crackers (450g; UPC 6 84431 00113 5). The recalled products were distributed across Canada.
  • Allergy Alert: Walmart Canada Corp. recalls Original Gourmet brand Passion Cookies (0.88 oz/25g pkg; Product of Turkey; Best before 11 05 2012 LH 031), because the product contains undeclared hazelnuts and may also contain other undeclared tree nuts. The recalled products were distributed across Canada.
  • Allergy Alert: Eurotrade Import-Export recalls Nutrafruit Plum Butter (750mL; All codes), due to the presence of undeclared sulphites. The recalled product was distributed in Ontario.
  • Outbreak Alert: One unit of the Colchester Regional Hospital (Truro, NS) has been shut down due to an outbreak of gastrointestinal illness that has affected 15 patients and staff members.

Europe

  • Allergy Alert (UK): Asda withdraws Asda Layered Prawn Salad (440g; Use by 2 February 2012), because the product is labeled incorrectly as Asda tuna layered salad and, therefore, does not mention prawns.
  • Food Safety Withdrawal (Ukraine): Agromars has withdrawn several batches of  poultry meat after Salmonella was found in the products during a scheduled government inspection. As many as 30,000 tonnes of chicken may be affected.
  • Dietary Supplement Safety Recall (Spain): Spanish health authorities order the recall of Doimas Capsules, because they were found to contain the illegal and undeclared ingredient nitrosoprodenafil.
  • Outbreak Alert (Scotland): A norovirus outbreak struck staff and patrons of Troon Restaurant, overlooking Troon Yacht Haven (Ayrshire) last weekend.
  • Outbreak Alert (Kyrgyzstan): Nine cases of botulism were reported in Bishkek during January. Two patients are in intensive care. The source of the outbreak was determined to be homemade preserves.
  • Outbreak Alert (Russia): Twenty-seven kindergarten children and three adults from one school and one child from a different preschool in Kolosok were diagnosed with Salmonella infections after consuming substandard. Six of the children were hospitalized.
  • Food Safety Notification (EU #2012.0154): Salmonella Amsterdam in teff meal from the Netherlands; distributed to Sweden.
  • Food Safety Notification (EU #2012.0155): Lead in pig fat from Poland; distributed to Hungary.
  • Food Safety Notification (EU #2012.0156): Parasitic infestation with Acanthocephalus (in muscle) of canned natural saury in oil or in own juice from Russia; distributed to Lithuania.

Asia, Africa and the Pacific Islands

Latin America and the Caribbean

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall web site.

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.
**Includes Safeway, Vons, Pavilions, Dominick’s, Genuardi’s, Randalls, Tom Thumb, Carrs and Pak N’ Save.

Novartis Fiasco Affects Pet Meds, Too

The recent shut-down of Novartis Consumer Health’s production facility in Lincoln, Nebraska has affected more than just Excedrin, Bufferin, NoDoz and Gas-X products. Veterinarians and pet owners also have been feeling the impact of Novartis’s abrogation of its quality assurance and product safety responsibilities.

Since issuing its product recall notice on January 8, 2012, the company has twice sent Dear Doctor letters to the veterinary community. The first letter, dated January 10th, warns veterinarians that the temporary suspension of production at the company’s Lincoln, Nebraska plant would affect the availability of certain Novartis Animal Health products. The letter begins:

Dear Valued Customer,

We are writing to inform you that Novartis Consumer Health, Inc. (NCH) has temporarily suspended production and product shipments at one of its manufacturing facilities, an action that will affect the availability of some Novartis Animal Health (NAH) products for the immediate future.

The manufacturing plant products both over-the-counter (OTC) and Animal Health products. NAH brands affected include Interceptor® Flavor Tabs®, Sentinel® Flavor Tabs®, Clomicalm®, Program® Tablets and Suspension, and Milbemite®. Production of Deramaxx, which was recently moved to the site, is also affected, although supplies on hand will continue to be shipped.

The second letter, which is dated January 25, 2012, is headed “IMPORTANT PRODUCT INFORMATION” and reads as follows:

Dear Doctor:

Novartis Animal Health US, Inc. is committed to delivering safe and efficacious veterinary products, and would like to inform you about a recent development involving CLOMICALM® (clomipramine hydrochloride) tablets.

Due to potential packaging issues at our manufacturing facility, there is a rare possibility that a wrong tablet may be found in bottles of CLOMICALM with the enclosed lot numbers. Novartis has not received any reports where a patient experienced a product mix-up, nor has Novartis received any adverse events attributable to a product mix-up. However, as a precautionary measure, we would like to extend the following recommendations.

1) Before dispensing CLOMICALM, open each bottle and examine the contents for tablets that are broken or incorrect in color, shape or size (visual guide included).

2) Post a copy of the Dear Valued Customer letter issued by Novartis Animal Health in your clinic (copy included).

3) Distribute copies of the Dear Valued Customer letter to affected pet owners. Novartis Animal Health will send your clinic extra copies upon request. If you publish a clinic newsletter, please consider using the provided notice.

4) Report any abnormal findings to Novartis Animal Health at 800-637-0281.

5) Return affected product to Novartis Animal Health; call the aforementioned number for full details.

6) Inform your clients who have already received CLOMICALM to examine tablets and refrain from administering any that are questionable in color, shape or size; and to contact Novartis Animal Health to discuss product return of affected bottles.

7) Keep records of communication with pet owners in patient files.

8) Ensure that any re-packaged tablet bottles are labeled with the product lot number.

Novartis Animal Health requests that you complete and return the enclosed Response Card reflecting that you have read and understand these points, and have discussed them with your clients.

Canine separation anxiety is a complex disorder that has great bearing on patient quality of life and the human-companion animal bond. Uninterrupted treatment is essential for successful management of this condition. Our veterinarians are prepared to discuss best practices with you in the event patients require alternative therapies, in order to minimize the risk of adverse events and potential relapse of signs.

We thank you for your attention and cooperation regarding this important issue. If you have any further questions, please contact Technical Product Services and Pharmacovigilance at 1-800-637-0281.

If you are using any of these Novartis Animal Health brands, please keep in close touch with your veterinarian to stay current on supply and quality issues.