Month: June 2011

A Company Errs On The Side Of Safety

On May 17, 2011, Nielsen-Massey recalled Madagascar Bourbon Pure Vanilla Bean Paste (Lot #11123) after its outside testing lab reported having found Listeria monocytogenes in a routine test sample.

The company also notified FDA and dispatched a recall letter to its customers within 24 hours of receiving the lab’s test results.

I have just received the following news release issued by Nielsen-Massey, which is self-explanatory.

Nielsen-Massey Vanillas’ Voluntary Product Recall Was Unnecessary

Found to be Based on Laboratory’s Error 

WAUKEGAN, Ill. (June 9, 2011) A voluntary recall of Nielsen-Massey Vanillas’ Madagascar Bourbon Pure Vanilla Bean Paste has been found to be based on a false-positive Listeria reading reported by the company’s outside testing laboratory. Subsequent investigations and further tests by the FDA, the outside lab in question and another independent lab brought in to re-verify the results, all came back negative. There were no positive results in any raw material used or for any of the equipment used in the process. Additionally, the other independent lab and the FDA laboratory, using the exact same gallon bottle of Paste which tested positive initially, found no trace of Listeria whatsoever. As the FDA did not have any findings as a result of their investigation, no Form 483 was issued.

On May 16, 2011, Nielsen-Massey’s outside testing laboratory advised Nielsen-Massey that it had detected potential Listeria monocytogenes contamination in lot no. 11123 of its Madagascar Bourbon Pure Vanilla Bean Paste product as part of its regular quality control testing. Nielsen-Massey acted immediately, notifying the FDA and writing and dispatching a recall letter to its customers within 24 hours of the lab’s notification. There have been no reports of illness related to Nielsen-Massey’s.

This recall did not affect Nielsen-Massey’s other products.

“We acted immediately when consumer safety became an issue,” said Craig Nielsen, chief executive officer. “And we would do the same thing again, since an error on the side of safety is almost always the right thing to do. But it’s extremely unfortunate that a laboratory error caused such inconvenience to our customers and consumers. We’ve notified all our customers and have apologized to them as well.

“For 104 years we have provided the world’s finest vanilla products made with the utmost care and safeguards. Nielsen-Massey remains committed to providing the world’s finest vanilla for the best customers in the world.”

My compliments to Nielsen-Massey’s management for erring on the side of consumer protection and food safety!

Recalls and Alerts: June 7, 2011

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

  • Consumer Product Safety Recall: MGA Entertainment (Van Nuys, CA) recalls Bratz Makeup Design Sketch Book (produced between November 5, 2010 and February 25, 2011), because the product has the potential to be contaminated with Staphylococcus warneri and Staphylococcus intermedius. Finished product testing determined that the eye shadow portion of the product contains elevated levels of bacteria.
  • Consumer Product Safety Recall: EKSuccess Brands recalls American Girl Crafts™ Pearly Beads & Ribbon Bracelets Kits (Product of China), because the surface coating on some of the beads contains excessive levels of lead. The recalled kits were sold at Michaels Stores and other retailers nationwide from September 2009 through June 2011.
  • FDA Enforcement Action: U.S Marshals, at the request of FDA, have seized probiotic products from UAS Laboratories, Inc. (Eden Prairie, MN) because the company markets the probiotics as drugs. The seized products include DDS Acidophilus, DDS Plus, Probioplus DDS, DDS Junior, and Cran-Gyn DDS, in capsule, powder, and tablet forms.
  • FDA Warning Letter: FDA warns Nature Pure LLC (West Mansfield, OH) that environmental swab samples taken during a February 2011 inspection of the company’s shell egg production facility were found to be positive for Salmonella Enteritidis. During the initial inspection and a follow-up inspection on February 28 through March 2nd revealed violations of the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (shell egg regulation).
  • FDA Warning Letter: FDA warns Lumen Soy Foods, LLC (Spring Lake, MI) that a February/March 2011 inspection of the company’s soy protein meatless meat products processing facility revealed serious violations of FDA’s Current Good Manufacturing Practice requirements in Manufacturing, Packing, or Holding Human Food.
  • FDA Warning Letter: FDA warns Cerebral Health, LLC that a February 2011 inspection of the company’s dietary supplement facility revealed that the company failed to comply with the requirements for Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements, causing your products to be adulterated.
  • FDA Warning Letter: FDA warns Jensen Tuna, Inc. (Houma, LA) that a January/February 2011 inspection of the company’s seafood processing facility revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
  • FDA Warning Letter: FDA warns Jonlly Fruits, Inc (Bayamón, PR) that a September/October 2010 inspection of the company’s fruit juice and fruit juice beverage processing facility revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation.
  • FDA Warning Letter: FDA warns Sunrise Orchards, Inc. (Goshen, IN) that an October 2010 inspection of the company’s juice processing facility revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation and the Current Good Manufacturing Practices (CGMP) regulation for food.

Canada

  • Allergy Alert: Brothers Bakery Inc. recalls a number of Brother Bakery brand baked goods (Best before dates up to and including June 12, 2011). Some of the recalled items are mislabeled; others contain undeclared milk, egg or sulphites. The recalled baked goods were distributed to retail stores in New Brunswick.
  • OTC Pharmaceutical Product Safety Recall: Tanta Pharmaceuticals Inc. recalls all lots of Junior Strength Acetaminophen Tablets (160mg) and Children’s Strength Acetaminophen Tablets (80 mg), due to reports that the Child Resistant Packaging is faulty. Please navigate to the Health Canada recall notice for details on brands and distribution information.
  • Food Safety Recall (Expanded): Tree of Life Canada (Surrey, BC) recalls King James brand Blue Stilton Cheese, 8-kg size units (Product of England; all lot codes and best before dates), because the product may be contaminated with Listeria monocytogenes. The cheese is mostly cut and sold at retail/deli counters in random weight packages, and has been distributed nationally.

Europe

  • Food Safety Recall (Norway): Mel Kvelde AS recalls wheat bran (Batch #122011) after the mycotoxin DON was detected in the production batch. The recalled wheat bran was sold only to bakeries and was not available in retail stores.
  • Food Safety Recall (Denmark): Gravenstein Poultry Ltd. recalls Gravenstein Poultry organic chicken (Best before date 01.06.2011), because samples of the poultry were found to contain multi-drug resistant Salmonella.
  • Outbreak Alert (Russia): Eleven children, ages 3 to 12, from a children’s home in Kirov have been hospitalized with an acute enteric infection. All of the children are in satisfactory condition.
  • Outbreak Alert Update (Germany): As of June 6, Germany has reported 642 cases of HUS (15 deaths), and 1,683 cases of non-HUS EHEC infections (7 deaths), for a total of 2,325 cases (22 deaths) within Germany. Twelve other European countries have reported a total of 31 HUS cases (1 death) and 73 cases of non-HUS EHEC.
  • Allergy Alert Notification (EU #2011.0744): Undeclared Brazil nut in nut and raisin mix from Germany; distributed to the Czech Republic.
  • Allergy Alert Notification (EU #2011.0747): Undeclared sulphite in sliced mushrooms in brine from the Czech Republic; distributed to Slovakia.
  • Food Safety Notification (EU #2011.0748): Parasitic infestation with Anisakis of anchovy from Croatia; distributed to Italy.
  • Food Safety Notification (EU #2011.0749): Formetanate in peppers from Turkey; distributed to Austria.

Asia, Africa and the Pacific Islands

  • Food Safety Advisory (Hong Kong): The Centre for Food Safety calls on the food trade to immediately stop the use and sale of 23 kinds of fruit syrup and juice (Annex), which were produced in Taiwan and might have been contaminated with di(2-ethylhexyl) phthalate (DEHP), a plasticiser.
  • Food Safety Enforcement (Abu Dhabi): Abu Dhabi’s Food Control Authority has ordered the closure of the Hamdan Street branch of Chilis restaurant, after an inspection of the premises found several violations of food safety regulations.

Australia and New Zealand

  • Food Withdrawal (Australia): Two-litre and 3-litre Coles brand milk (Expiry June 18) and Dairy Farmer two-litre and three-litre milk (Expiry June 19) has been withdrawn from store shelves due to a problem with the homogenization process. This is not a safety issue.

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.

Recalls and Alerts: June 6, 2011

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

  • Dietary Supplement Safety Recall: Global Wellness, LLC (Hollywood, FL) recalls VIA Xtreme Ultimate Sexual Enhancer Dietary Supplement For Men (Lots #809013 and 806030), after FDA lab analysis finds sulfoaildenafil, methanesulfonate, sulfosildenafil and dimethylsildenafil analogs of sildenafil (an active ingredient of an approved prescription drug used to treat erectile dysfunction. The recalled product was distributed throughout the USA, Puerto Rico and Canada to Internet and retail consumers.
  • Pharmaceutical Product Safety Recall: American Regent recalls Methyldopate HCl Injection, USP, 250 mg/5mL, 5 mL single-dose vial (Lot #0152; Expiry date March, 2012), because some of the vials contain translucent visible particles consistent with glass delamination. The recalled product was distributed to wholesalers and distributors nationwide.

Canada

  • Allergy Alert: Nonuttin’ Foods Inc (Duncan, BC) recalls Fruit Explosion Train Mix, Berry Delight Train Mix, Raw and Shelled Sunflower Seeds, Blueberry Maple Granola and Cranberry Apple Granola (Best before dates up to and including May 31, 2012), because these nationally distributed products may contain undeclared sesame. One adverse reaction has been reported.
  • Allergy Alert: Quality Natural Foods Ltd. recalls Haldiram’s Rajbhog, 1-kg size, because some packages of the product contain undeclared sulphites. The recalled product was sold at retail stores nationally.
  • Food Supplement Safety Recall: Simply Thick, LLC recalls Simply Thick® thickening gel products manufactured at the Thermo Pac, LLC food processing plant in Stone Mountain, Georgia, because the U.S. Food and Drug Administration (FDA) advised the company that Thermo Pac, LLC failed to file with the FDA a scheduled process designed to ensure that vegetative cells (harmful bacteria) of possible public health significance are destroyed during the manufacturing process. This failure was discovered during an FDA inspection of the Thermo Pac, LLC Stone Mountain plant conducted from May 23 through June 3, 2011.
  • Dietary Supplement Safety Recall: Global Wellness, LLC (Hollywood, FL) recalls VIA Xtreme Ultimate Sexual Enhancer Dietary Supplement For Men (Lots #809013 and 806030), after FDA lab analysis finds sulfoaildenafil, methanesulfonate, sulfosildenafil and dimethylsildenafil analogs of sildenafil (an active ingredient of an approved prescription drug used to treat erectile dysfunction. The recalled product was distributed throughout the USA, Puerto Rico and Canada to Internet and retail consumers.

Europe

  • Dietary Supplement Safety Alert (Switzerland): Swissmedic, the Swiss Institute for Therapeutic Products advises the public that a recent sampling of 122 imported weight-loss products revealed that most of the products are associated with a hazard to health. More than one-half of the products suffered from serious quality defects; nearly 90% contained unsafe active ingredients. Some products contained dangerous concentrations of sibutramine.
  • Outbreak Alert Update (E. coli O104:H4): As of June 5th, Germany reported 630 cases of HUS (including 15 fatalities) and 1601 cases of non-HUS EHEC infections (6 deaths), for a total of 2231 outbreak-related illnesses. Twelve other European countries have reported a total of 31 cases of HUS (1 death) and 73 non-HUS EHEC cases, for a total of 104 illnesses.

Asia, Africa and the Pacific Islands

  • Food Safety Alert (Hong Kong): The Centre for Food Safety has alerted industry and the public to seven kinds of fruit juice/syrup and powder for manufacturing confections (all products of Taiwan) that may be contaminated with DEHP. The trade has been instructed to immediately stop the use and sale of the named products.
  • Food Safety Recall (Singapore): Agri-Food & Veterinary Authority of Singapore has suspended the import of Tachungo brand fruit juice concentrates and instructed the importer to recall the products after DEHP was found in a sample of the products.
  • Food Safety Alert (Taiwan): Many bakeries have been found using jams and flour that can be traced back to Yu Shen Chemical Co., which has been using DEHP-contaminated clouding agents in their jams.

Australia and New Zealand

Latin America and the Caribbean

  • Dietary Supplement Safety Recall: Global Wellness, LLC (Hollywood, FL) recalls VIA Xtreme Ultimate Sexual Enhancer Dietary Supplement For Men (Lots #809013 and 806030), after FDA lab analysis finds sulfoaildenafil, methanesulfonate, sulfosildenafil and dimethylsildenafil analogs of sildenafil (an active ingredient of an approved prescription drug used to treat erectile dysfunction. The recalled product was distributed throughout the USA, Puerto Rico and Canada to Internet and retail consumers.

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.