Recalls and Alerts: February 6, 2013

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: The Kroger Company recalls Bakery Mardi Gras King Cake, Cinnamon (**1315), due to undeclared pecans. The recalled product was sold at Kroger stores in Georgia, South Carolina, Alabama and Knoxville, TN.
  • Allergy Alert: Marshallville Packing Co. Inc. recalls German Brand Beef Bologna, Garlic Beef Bologna, Beef Bologna, Trail Style Bologna, Dutch Brand Loaf, and Braunschweiger ready-to-eat meats, due to undeclared wheat.
  • Pharmaceutical Product Safety Alert: FDA has warned U.S. doctors about another counterfeit version of the cancer drug Avastin. The product, labeled as Altuzan (bevacizumab) 400 mg/16 mL, may be counterfeit if it displays Batch No. B6022B01 (Exp. date 11 2013) or B6024B01 (Exp. date 02 2013). FDA lab tests have confirmed that at least one batch of the counterfeit product contains no active ingredient.

Canada

  • Allergy Alert: AAA Boucherie Gourmet inc. (Montreal, QC) recalls Sauce Spaghetti Maison (All product sold up to 5 February 2013, inclusive) due to undeclared wheat, soy, milk or mustard).

Europe

Asia, Africa and the Pacific Islands

  • Proprietary Chinese Medicine Safety Recall (Hong Kong): Fung Wah (Hong Kong) Company (operated by Honour Essence Trading Limited) recalls Yunnan Baiyao capsules (registration number: HKP-00776; batch number: 48911104), Yunnan Baiyao powder (registration number: HKP-00775; batch number: 48971012), Yunnan Baiyao plaster (registration number: HKP-00255; batch number: 48971204), Yunnan Baiyao aerosol (registration number: HKP-00777; batch number: 48971107) and Yunnan Baiyao tincture (registration number: HKP-00805; batch number: 20110101C), as they have been found to contain undeclared aconitum alkaloids.

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 website.

*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.

Recalls and Alerts: February 5, 2013

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: Domega NY International Co., Ltd. (Brooklyn, NY) recalls Green Day brand Dried Coconut (3 oz/85g clear plastic bags; Exp 12/15/2014; UPC 6 950296 800744; Product of China), due to undeclared sulfites. The recalled product was sold in the NY Metro area.
  • Food Safety Recall: House’s Butchering, LLC (Versailles, OH) recalls Pork Bacon Thick Sliced (approx. 1 lb pkgs; ODA Est. 54; 5-digit code (if present) beginning with ’12’) and Beef Summer Sausage (approx 1.5 lb pkgs; ODA Est. 54; 5-digit code (if present) beginning with ’12’), because the products were packaged without a food safety program. The recalled products were sold only at House’s Butchering meat market.
  • Food Safety Recall: House’s Butchering, LLC (Versailles, OH) recalls all beef slaughtered and processed at House’s Butchering from 1/1/11 to 12/28/12 (Est. 54; 5-digit code beginning with ’11’ or ’12’), because the beef products may contain spinal cord and vertebral column materials.
  • Food Safety Alert (Missouri): The Missouri Department of Agriculture has halted custom exempt processing operations at Hilty’s Custom Meats (Bowling Green, MO) due to violations related to selling uninspected meat products to the public. An investigation is ongoing.
  • Outbreak Alert: Indiana State Department of Health has confirmed a case of typhoid fever in a food handler at Purdue University. Anyone who ate at the Boiler Bistro, John Purdue Room, or the coffee shop, Lavazza, at Marriott Hall on the Purdue campus from Jan. 23 to Jan. 25, 2013, may be at risk and should  consult a healthcare provider immediately if they start to experience symptoms of typhoid fever (including high fever, weakness, stomach pains, headache, nausea, vomiting, diarrhea, or loss of appetite). The incubation period for typhoid fever usually is 8-14 days after exposure, but could be as long as 30 days.
  • FDA Warning Letter: FDA warns Bellisio Foods, Inc. (Minneapolis, MN) that a November 2012 inspection of the company’s seafood processing facility found  serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
  • FDA Warning Letter: FDA warns NX Generation Ltd. (Hauppauge, NY) that a July 2012 inspection of the company’s dietary supplement packaging, labeling and distribution facility found serious violations of FDA’s Current Good Manufacturing Practice (CGMP) regulation for dietary supplements.
  • FDA Warning Letter: FDA warns Gioia Cheese Co., Inc. (South El Monte, CA) that an August 2012 inspection of the company’s cheese manufacturing facility found the presence of Listeria monocytogenes in three environmental swab samples from the processing facility, in addition to violations of the Current Good Manufacturing Practice regulation for food.
  • FDA Warning Letter: FDA warns Missa Bay, LLC (Irwindale, CA) that a July-August 2012 inspection of the company’s Swedesboro, NJ manufacturing facility found Listeria monocytogenes on food contact surfaces, on non-food contact surfaces, in samples of ascorbic acid dip solution, and in samples of diced apples and sliced apples. A total of 27 environmental samples were positive for the same strain of Listeria monocytogenes that was found in the finished product samples.
  • FDA Warning Letter: FDA warns Raw Deal, Inc. (Flanders, NJ) that a February-March 2012 inspection of the company’s facility found serious violations of the dietary supplement CGMP regulations.
  • FDA Warning Letter: FDA warns R & L, Inc. (Lima, OH) that a March-April 2012 inspection of the company’s seafood processing facility found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

Canada

  • Food Safety Recall: Plantation Nasenka (l’Assomption, QC) recalls Sauce à spaghetti (500 & 750 ml glass Mason jars), Chili Nasenka (500 ml glass Mason jars), Ragout écossais (500 ml glass Mason jars) and Salsa Dionisos (250 & 500 ml glass Mason jars), because the products were not prepared or displayed in a manner to ensure microbiological safety. The recalled products were sold without refrigeration up to and including February 1, 2013.

Europe

Australia and New Zealand

  • Food Safety Recall (Australia): Woolworths Ltd. recalls Woolworths Select Turkey Sliced 97% Fat Free (80g formed MAP pack; Use by 22/02/2013) due to foreign matter (clear plastic fragments) contamination. The recalled product was sold at Woolworths Supermarkets, Safeway, Food for Less and Flemings Supermarkets in QLD, SA and WA only.
  • Dietary Supplement Safety Recall (Australia): Nutri-Sups Worldwide Distribution Pty Ltd. recalls Albuterex Xtreme Formula, Albutarex Xtreme Formula and Albutarex Femme Formula after testing by the Therapeutic Goods Administration finds that batches of the three products contain undeclared theophylline and very high levels of caffeine. In addition, Albuterex Xtreme Formula also was found to contain undeclared yohimbine. Theophylline and yohimbine are prescription-only ingredients.

Latin America and the Caribbean

  • OTC Pharmaceutical Product Recall (Multiple countries): Novartis Pharma Logistics, Inc. recalls certain lots of Triaminic® Syrups, Theraflu Warming Relief® Syrups, Jack & Jill® brand pediatric syrups and Buckley’s® Complete Liquids, because the child-resistant feature of the bottle caps may not function properly, enabling the cap to be removed with the tamper-evident seal still in place. The recalled products were manufactured at a Novartis Consumer Health facility (Lincoln, NE) prior to december 2011. The Buckley’s Complete® also was manufactured until January 2013 at a third-party facility in Canada. The recalled products were supplied to retailers and wholesalers in Barbados, Aruba, Curaçao, the Bahamas, Trinidad & Tobago and Jamaica.

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 website.

*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.

Guest Blog: Salmonella’s Not an Adulterant?

The following Guest Blog first appeared on Food Safety News (February 2, 2013), and is reproduced here with the kind permission of its author, Bill Marler.

Salmonella’s Not an Adulterant?

– by William D. Marler

Personally, as I said to the Los Angeles Times several months ago, “I think that anything that can poison or kill a person should be listed as an adulterant [in food].”

Ignoring Salmonella in meat makes little, if any, sense. Even after the Court’s twisted opinion in Supreme Beef v. USDA, where it found Salmonella “not an adulterant per se, meaning its presence does not require the USDA to refuse to stamp such meat ‘inspected and passed,” our government’s failure to confront the reality of Salmonella, especially antibiotic-resistant Salmonella, is inexcusable. The Wisconsin Supreme Court in Kriefall v Excel called it as it saw it:

The E. coli strain that killed Brianna and made the others sick is a “deleterious substance which may render [meat] injurious to health.” There is no dispute about this. Thus, under the first part of 21 U.S.C. § 601(m)(1), meat that either “bears or contains” E. coli O157:H7 (the “deleterious substance”) is “adulterated.” That E. coli O157:H7 contamination can be rendered non-“injurious to health” by cooking thoroughly, as discussed below, does not negate this; Congress used the phrase “may render,” not “in every circumstance renders.” Moreover, if the E. coli bacteria is not considered to be “an added substance,” because it comes from some of the animals themselves and is not either applied or supplied during the slaughtering process (although we do not decide this), it cannot be said that the E. coli strain “does not ordinarily render [the meat on or in which it appears] injurious to health.” Accordingly, meat contaminated by E. coli O157:H7 is also “adulterated” under the second part of § 601(m)(1).

Now, why would Salmonella be different?

According to the CDC, it is estimated that 1.4 million cases of salmonellosis occur each year in the U.S. Of those cases, 95 percent are related to foodborne causes. Approximately 220 of each 1000 cases result in hospitalization, and 8 of every 1000 cases result in death. About 500 to 1,000 deaths – 31 percent of all food-related deaths – are caused by Salmonella infections each year.

So, where do we stand with the existing USDA/FSIS law on adulteration? Here is the law:

21 U.S.C. § 601(m)(4) – SUBCHAPTER I – INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING – CHAPTER 12 – MEAT INSPECTION – TITLE 21—FOOD AND DRUGS

(m) The term “adulterated” shall apply to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:

(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; …

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; …

Hmmm. It is hard to read the above and not think that the words in bold equate to all E. coli and Salmonella (frankly, all pathogens in food). I know, I am just a lawyer, but don’t ya think that when food with animal feces (and a dash of E. coli O157:H7) in it is considered an adulterant, that other animal feces (with dashes of other pathogens, like Salmonella) in them, should be considered adulterated too? But, hey, that is just me.

Another odd governmental fact is that the FDA does not seem to make a distinction between pathogens it considers adulterants or not. FDA’s enabling legislation – Sec. 402. [21 USC §342] of the Food, Drug & Cosmetic Act also defines “Adulterated Food” as food that is:

(a) Poisonous, insanitary, or deleterious ingredients.

(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health;

(2) If it bears or contains any added poisonous or added deleterious substance … that is unsafe within the meaning of section 406;

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health …

It would be interesting, and perhaps entertaining, to have House and Senate hearings focusing on what should and should not be considered adulterants in our food. I can see panels of scientists from various fields, FDA, USDA and FSIS officials, beef and produce industry representatives and consumers discussing this. I would pay to watch it.

About the author: Bill Marler is a personal injury and products liability attorney, and an internationally known food safety advocate. He began litigating foodborne illness cases in 1993, when he represented Brianne Kiner, the most seriously injured survivor of the Jack in the Box E. coli O157:H7 outbreak. Bill is a graduate of the Seattle University School of Law, and the Law School’s “Lawyer in Residence.”