Class I Allergen Recall of Fruit-Filled Pies
FDA Inspection Discloses Undeclared Eggs in Pies
An inspection by FDA’s New Jersey District Office of a manufacturing facility resulted in a Class I allergen recall of “Wholly Health Two Crust Pies” due to the presence of undeclared eggs. The firm, Run-A-Ton Group, Inc., of Morristown, New Jersey, voluntarily recalled all two-crust “Wholly Healthy” pies manufactured prior to April 27, 2002. The recall was nationwide and included approximately 6,000 cases. During an FDA inspection investigators observed an “egg wash” being applied to the crust of the pies. However, eggs were not declared on the label. The firm issued a press release on April 29, 2002. The recall number for this Class I recall is F-612-619-2.
Biscuits with Undeclared Milk Protein Recalled
FDA’s New England District Office reported that Great Brands of Europe, Inc., Wilton, Connecticut, recalled its Le PIM's soft biscuits (Orange and Pear) on March 14, 2002. The soft biscuits contained a fruit filling and were sold in the United States. The firm received one allergic reaction to milk protein, which resulted in the firm's recall. The products came in cardboard packaging of 150 g (5.29 ounce), in three flavors: Orange, Pear and Raspberry and were imported from and manufactured in Belgium. The product was produced on shared manufacturing lines and, therefore, cross-contamination was possible for milk and non-milk products. The Press Release was issued on March 14, 2002. The recall number for this Class I recall is F-643-645-2.
Biscuits Containing Insect Filth Destroyed
FDA Lab Analysis Finds Excessive Filth in Biscuits
On December 19, 2001, FDA’s Detroit District Office reported that investigators supervised the voluntary destruction of 1,000 cartons of Petit Beurge Biscuits (cookies) valued at $5,544. The products were imported by Max's Imports, Sterling Heights, Michigan. The product was detained after FDA’s Detroit District laboratory found excessive insect filth in the product. In addition, the product was not labeled as required by FDA regulations. The importer decided to voluntarily destroy the article under FDA supervision rather than export the product.
Routine FDA Inspection Discloses Undeclared Egg in Buns
Inspection of Bakery Discloses Mislabeling of Onion Buns
An FDA bakery inspection of Sara Lee Bakery Group, St. Louis, Missouri, disclosed mislabeling of the firm’s product, Earth Grains Onion Buns. The product contained eggs which were not disclosed on the label. Sara Lee Bakery Group, St. Louis, Missouri, issued a Press Release on June 17, 2002, announcing the recall of Earth Grain Onion Buns. The recall involved 8 count, 19 ounce packages of Earth Grains Onion Buns marked for purchase between June 15 and 28, 2002. The firm suspended production and the mislabeled packages were removed from store shelves.
Consumption of this product by people who have an allergy or sensitivity to eggs could result in a serious or life threatening allergic reaction. This product only poses a potential hazard to egg sensitive individuals. The buns are safe for all other people to consume. The company had not received any consumer complaints regarding these buns.
Sara Lee Bakery Group worked together with FDA in undertaking a voluntary recall of this product and also notified the Food Allergy and Anaphylaxis Network. The buns were distributed in all or parts of the following states: Alabama, Arkansas, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Minnesota, Mississippi, Missouri, Nebraska, North Carolina, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia and Wisconsin. The recall number for this Class I recall is F-681-2.
Allergy Alert for Undeclared Eggs and Milk in Sweet Rolls
FDA conducted an inspection of An Xuyen Bakery, Seatac, Washington, on June 4-6, 2002. The inspection disclosed that 12 ounce packages of sweet rolls contained undeclared eggs and milk. People who have an allergy or severe sensitivity to eggs or milk run the risk of serious or life-threatening allergic reaction if they consume this product. The sweet rolls were distributed to Asian retail markets in Seattle, Washington. The firm issued a recall notice on June 6, 2002.
The sweet rolls were packaged in a clear plastic bag labeled An Xuyen Bakery and a picture of 3 different bread products. Each bag contained 12 rolls. The product name, sweet rolls, was not stated on the package. There was no manufacturing code on the product. Consumers who purchased An Xuyen Bakery sweet rolls were urged to return it to the place of purchase for a full refund. The recall number for this Class I recall is F-596-2.
White Grape Juice Concentrate Seized
Sample Analysis by FDA Finds Excessive Lead In Grape Juice
On December 26, 2001, FDA investigators accompanied the U.S. Marshals Service in a seizure of 136/58 gallon drums of Argentine white grape juice concentrate held at Americold Logistics LLC. The product was stored under the account of M&B Products Inc., Tampa, Florida. The concentrate was found adulterated due to the presence of excessive amounts of lead. G.B. International, Madison, New Jersey, the importer and current owner of the concentrate, valued the lot at $45,000. FDA sample analysis found the product contained 79.5 mg/L lead at single strength dilution.
The elevated level of lead was especially significant in that the concentrate was intended to be used to manufacture juice for school lunch programs. FDA’s Center for Food Safety and Applied Nutrition (CFSAN), Division of Risk Assessment, concluded that the lead posed a long-term moderate health hazard for toddlers and young children.
Boxed Candies Recalled Due to Undeclared Egg Whites and Yellow #6
FDA’s Seattle District Office reported that on May 9, 2002, Moonstruck Chocolate Co., Portland, Oregon, initiated a Class I recall of their CLASSIC 9 piece, CLASSIC 16 piece, and 12 Piece Spring Collection boxed candies due to undeclared egg whites and yellow #6. The boxed candies contained a toffee truffle with a flower decoration on top. The flower decoration contained the undeclared egg whites and yellow #6. The products were sold in retail stores and through mail order. The firm issued a nationwide Press Release on May 9, 2002. The recall number for this Class I recall is F-496-498-2.
Imported Candy Seized
FDA’s Southwest Import District (SWID) recommended the seizure of 192 cases of Hormigas candy that was found to be in whole or partly substituted for candy refused admission by FDA. The candy was manufactured by Productos Indy SA de CV, Mexico, imported by Lucas World, Inc., and refused admission by FDA due to filth contamination.
The SWID Laredo Report Post personnel accompanied U.S. Customs’ special agents to assist in the actual seizure of the substituted merchandise. In addition to the seizure, SWID recommended that U.S. Customs assess liquidated damages against the importer for failure to redeliver the actual merchandise refused admission by FDA.
Konjac Candy - FDA Issues Warnings to Public and Import Alert
FDA Issues Second Warning of Danger of Choking on Konjac Candy
On October 5, 2001, FDA issued a second warning to the public concerning the serious choking hazard caused by konjac candy. FDA issued the first warning on August 17, 2001. Konjac candy is a fruit-flavored gel candies in various flavors that is imported primarily from Asia and has been linked to six deaths in children in the United States. FDA decided a second warning was warranted after consultation with experts on choking from the Consumer Product Safety Commission (CPSC). CPSC staff confirmed that these candies posed a serious choking risk, particularly to infants, children and the elderly. FDA also issued an import alert to address the problem of importation of these candies from other countries. The agency worked with numerous firms in a nationwide recall of these candies. One firm, New Choice, refused to recall their candies and the product was seized by FDA following repeated attempts to get the firm to recall the candies.
Numerous Recalls of Konjac Candy
- FDA announced a recall by Thomas Diaz, Inc., of Toa Baja, Puerto Rico, of 1,500 cartons of Fruzel assorted Natural Fruit Jelly Candy because these products present a choking hazard. The product was distributed to wholesale and retail establishments throughout Puerto Rico under the " Neo USA" brand. The mini jelly candies came in assorted flavors. Each mini jelly cup is about the size of single serve coffee creamer. The candies were packaged in 16.5 gram jars with 88 units per jar.
- On May 17, 2002, FDA announced a recall by Everlasting Distributors, Inc., of Bayonne, New Jersey, of 1,197 cases of mini jelly candies (or mini cup gel candy) because these products presented a choking hazard. The product was distributed to retail establishments throughout New York, Massachusetts, Illinois, Florida, Georgia, Maryland, New Jersey, Pennsylvania and Virginia under the "ABC" brand.
- On April 25, 2002, FDA announced a recall by Yoli, Inc., Chicago, Illinois, of 3,115 bags of mini jelly candies (or mini cup gel candy) because these products present a choking hazard. The product was distributed in bags which read in part; "Mi Costenita . . ... Gelatinas Coconut Jelly" to retail establishments in Illinois, Michigan, Ohio, Indiana, Tennessee, Arkansas, Missouri, Mississippi, Kansas, Alabama, Georgia, North Carolina and Wisconsin.
- On April 25, 2002, FDA announced a recall by Lien Hoa Food Corp., Chicago, Illinois, of 464 cases of mini jelly candies (or mini cup gel candy) because these products present a choking hazard. The product was distributed to retail establishments throughout northern Illinois and Wisconsin under the "Jojomo" and "Naluwan" brand. The label described the product as "JM Jojomo" and "Naluwan Nata De Coco Konnyaku Jelly" in all flavors. The candy came in small creamer sized sealed plastic cups.
- On April 5, 2002, FDA announced recalls from G. L. Food Wholesale Inc., City of Industry, California, and Philippine Foodtrade Corporation, Vernon, California, of 100 cases of mini jelly candies (or mini cup gel candy) because these products present a choking hazard. The product was distributed to retail establishments throughout southern California under the "Sugarland" brand. The label described the product as "Jellyace Buko Pandan." The candy came in small sealed plastic cups.
- On February 15, 2002, FDA reported a recall by Golden Country Oriental Food, Chicago, Illinois. These candies were distributed in Illinois, Iowa, Indiana, Kentucky, Ohio, Wisconsin, Florida, Michigan, Missouri, South Dakota, and Kansas. The three brand names included “Don Empire,” another with no brand name and only Chinese characters and butterflies on the label, and "My Love and Coco.” The individual serving cups were packaged in 300 gram plastic bags with 30 bags per case, 510 gram plastic panda bear shaped jars with 12 jars per case, and 1200 gram round plastic jars with 6 jars per case. Golden Country Oriental Food requested a recall through its distributors and retailers to consumers, who were urged to return this product to the place of purchase.
- Five Continents, Ltd., Chicago, Illinois, recalled konjac candies that were distributed in Indiana, Illinois, Nebraska, Michigan, Kentucky, Ohio, Wisconsin, Missouri, Texas, Iowa, New Jersey, Kansas and South Dakota. The brand name was “ABC” brand Konjac Coconut Jelly Mini Fruit Bites Candy. The individual serving cups were packaged in 300 gram plastic bags with 30 bags per case and 1500 gram plastic round and panda bear shaped with 6 jars per case. Consumers were urged to return this product to the place of purchase.
- On January 30, 2002, FDA announced the recall by Anhing Corporation, Los Angeles, California, of Rolin Brand "Lychee Nata De Coco Jelly" because this product presents a choking hazard. These candies were distributed nationwide. The candies were packaged in small sealed plastic cups. Each mini jelly cup was about the size of a single serve coffee creamer.
- January 15, 2002, FDA announced a recall by Walong Marketing, Inc., Buena Park, California, of “Mini Jelly Snack Cups” because this product presents a choking hazard. These candies were distributed nationwide and internationally under the brands “Kimbo,” “Asian Taste,” “Jin Jin,” and “Shen Hsiang Jen Foods.” The candies were packaged in small sealed plastic cups.
- On December 7, 2001, FDA announced the recall of approximately 16,000 packages of mini cup gel candies because they present a choking hazard. This candy, distributed nationwide to retail establishments, was sold under the names of “Mother's Pride” and “NATA,” and the label described the product as a mini-fruit bite. The candy came in small sealed plastic cups that contained gelatin with or without a chunk of fruit.
- On July 23, 2002, FDA’s Philadelphia District Office announced that Santi and Sons, Reading, Pennsylvania, initiated a recall of mini gel candies and issued a Press Release to alert the public of the potential choking hazard associated with the product. On July 30, 2002, the district witnessed the destruction of 960 cases of mini gel candies with an approximate value of 15,360. The recalled candies were disposed at Conestoga Landfill, Morgantown, Pennsylvania. These candies were sold under the following brand names: “New Choice Mini Fruit Gels,” “Yummy Choice Fruit Gel Snacks,” and “Sheng Hsiang Jen Conjac Coconut Jelly.” These candies were sold in the following flavors: apple, grape, taro, lychee, peach, pineapple, mango, orange, lemon, strawberry, and assorted flavors. Santi and Sons retrieved the recalled product from their consignees and destroyed the recovered product. The district monitored the recall until completion.
Konjac Candy Voluntarily Destroyed
On February 20, 2002, FDA’s Chicago District Office Investigators and the City of Chicago Department of Public Health cooperatively witnessed the voluntary destruction of 1,390 cases/30/300 gram plastic bag containers and 1,392 cases/6/1500 gram plastic jar containers of “ABC Mini Jelly” candies under embargo at Five Continents in Chicago, Illinois. The candy included products collected from Five Continents and embargoed product at an affiliated sister firm under the same ownership, Wu Chu of Chicago, Illinois, following inspections of the firms.
The recalled products were part of the konjac candies being recalled as a choking hazard. The value of the destroyed products was $39,687.80. Five Continents anticipated continued receipt of recalled products from their sub accounts.
Seizure of "Konjac" Candy
Firm Fails to Recall Candy Which Causes Choking – Product is Seized
On May 22, 2002, New Choice Food's mini gel candies were seized at the firm's facility in Irwindale, California. FDA took this action after the agency determined that the candies presented a serious choking hazard. Prior to the seizure, the State of California was holding the products under an embargo. FDA scientists and staff physiologists from the Consumer Product Safety Commission concluded that the packaging, shape, slipperiness, and consistency of the products all contributed to the product's inherent choking potential. Thus, the articles are adulterated under 21 U.S.C. § 342(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act), in that they are unfit for food because they pose a serious choking hazard.
These candies contained an ingredient "konjac" (also known as congac, konnyake, yam flour, or glucomannan) and, unlike gelatin products, do not readily dissolve when placed in the mouth.
Numerous companies have recalled these konjac candies. New Choice, however, did not recall their candies. FDA conducted an inspection of the firm in Irwindale, California, in January 2002. The company failed to cease distribution of the product and to voluntarily recall product currently on the market.
Under these circumstances, seizure of the goods was necessary. FDA issued a letter to the U.S. Attorney requesting that a Complaint for Forfeiture be filed in the U.S. District Court. The Complaint charged that the products were adulterated within the meaning of 21 U.S.C. § 342(a)(3), and misbranded within the meaning of 21 U.S.C. §§ 343(a)(1), 343(i)(1), 343(i)(2), and 343(r)(1)(A) of the Act, and adulterated within the meaning of 21 U.S.C. § 342(a)(3).
Each gel cup was about the size of a single serve coffee creamer. The gel cups were sold in 250 gram (8.75 ounce) and 300 gram (10.5 ounce) plastic bags or in 1100 gram (38.5 ounce) and 1500 gram (52.5 ounce) plastic jars. Some labels of these products bore a warning suggesting that they are a choking hazard, and some labels stated that they should not be consumed by children of various ages, ranging from 3 to 6 years of age.
Seizure of Honey with Chloramphenicol
FDA Lab Analysis Finds Chloramphenicol in Honey
On August 28, 2002, FDA investigators from the New Orleans District accompanied the U.S. Marshals Service in a seizure of imported bulk, in-process, and finished product honey located at Besseonet Bee Company, Davidsonville, Louisiana. The product was valued at approximately $50,000.00. A sample of the imported bulk honey, collected by the New Orleans District, was tested by FDA’s Denver District Laboratory and found to contain chloramphenicol at or above the level of 1 part per billion (ppb). The Louisiana Department of Agriculture and Forestry also conducted tests on samples of the imported honey and found the product contained chloramphenicol.
Chloramphenicol is a broad-spectrum antibiotic approved for use in humans with serious infections when other, less toxic, drugs are ineffective. It has not been possible to identify a safe level of human exposure to chloramphenicol due to the unpredictable dose-response on different patients. The main toxic effect of chloramphenicol in humans is the development of a type of bone marrow depression (aplastic anemia) in susceptible individuals. This condition is usually irreversible and fatal. In addition, the onset of the condition is not dose dependent.
Prior to seizure, FDA had issued a letter to the U.S. Attorney on August 27, 2002, requesting that a Complaint for Forfeiture be filed in the U.S. District Court. The Complaint charged that the products were adulterated within the meaning of 21 U.S.C. § 342(a)(2)(C)(i) of the Act, because they contained a food additive, namely chloramphenicol, that is unsafe within the meaning of 21 U.S.C. § 348, and that the products were misbranded within the meaning of 21 U.S.C. §§ 343(a)(1) and 321(n) of the Act. The finished food was misbranded under 21 U.S.C. § 343(a)(1)because the label bears the statement "no additives," which is false and misleading in that the article contains the food additive chloramphenicol; and 21 U.S.C. § 343(a)(1) and 21 U.S.C. § 321(n) because its labeling is false and misleading in that it failed to reveal that the article contains chloramphenicol, a fact material with respect to adverse health consequences that may result from the consumption of the article.
Warning Letter Issued to Canned Food Manufacturer
FDA Inspection Finds Problems in the Manufacturing of Low-Acid Canned Food
On February 15, 2002, FDA’s Minneapolis District Office issued a Warning Letter to the Trival General Manager, Tsyunhehkwa, Oneida, Wisconsin. Tsyunhehkwa is a low-acid canned food (LACF) and acidified food manufacturer operated by the Oneida Indian Tribe. The products manufactured by this tribe include White Corn Soup with Pork, White Corn Soup with Turkey, Dill Pickles, Hamburger Dills, and Pickle Relish. The Warning Letter was issued as a result of an FDA inspection conducted on August 15 - 20, 2001.
The Warning Letter cited the firm for failure to appropriately handle process deviations in scheduled processes. Additional violations cited in the Warning Letter included the following: failure to handle deviations less than scheduled processes; failure to file a process for a low-acid canned food or for acidified food; failure to test and record equilibrium pH in acidified foods; failure to maintain thermal records as required; failure to maintain a deviation file or log; failure to establish and maintain container closure examination records as required; and failure to measure and record initial temperature, among other deviations.
Damaged Canned Tomatoes Destroyed
On November 5 - 8, 2002, FDA’s New Orleans District Office conducted an inspection of Farmers Seafood Kitchens, a warehouse located in Shreveport, Louisiana. The inspection revealed that approximately 60 percent of unlabeled cans of diced tomatoes in heavy puree were damaged, including several swollen cans. On February 12, 2002, FDA officials witnessed the voluntary destruction of 10,743 unlabeled cans of diced tomatoes in heavy puree, valued at $13,321.00 that were held in the warehouse.
The product was received from Veronica Foods, Oakland, California, and manufactured by Tri Valley Growers, Modesto, California. Farmers Seafood Kitchens used the product as an ingredient in several of its products, such as Shrimp Creole and Crawfish Etoufe entree. An analysis by FDA’s Southeast Regional Laboratory of samples of the cans demonstrated seam defects along with gram positive microbial contamination in the product.
FDA Witnesses Destruction of Seized Goods
Officials of FDA’s New York District met with deputies from the U.S. Marshals Service at Well Luck, Inc., an importer located in Jersey City, New Jersey. FDA witnessed the destruction by default judgment, following seizure, of 196 cases of canned stripped bamboo shoots, 896 cases of sliced bamboo shoots, and 1,120 cases of straw mushrooms. The total value was $16,240. The misbranded cases were placed into four, thirty-yard containers and were transported to Solid Waste Transfer & Recycling, Inc., Newark, New Jersey. Cases were unloaded and crushed.
Airline Caterer Suspended
FDA’s New York District Office conducted an inspection of Borenstein Caterers, Inc., Jamaica, New York, on May 1 - 2, 2002. The inspection revealed violations of the U.S. Public Health Service Act and its implementing regulations for the Control of Communicable Diseases and Interstate Conveyance Sanitation [Title 21, Code of Federal Regulations Parts 1240 and 1250]. FDA issued a Warning Letter to the firm on June 5, 2002, advising the firm of the inspectional findings.
The violations observed during the inspection included: failure of employees in the salad preparation area to wash their hands before returning to work after the lunch break; employees in the silverware packaging area handled surfaces of the silver that made contact with the user’s mouth; the wash water temperature gauge on the multi-tank automatic dishwashing machine and the rinse water temperature gauge on the single tank automatic dishwashing were inoperable.
Also, both dishwashing machines lacked a valve to permit checking the flow pressure of the final rinse water. In addition, there was no test kit available to determine the concentration of the chemical sanitizing solution, and there was no hand washing sink to permit convenient use by all employees in the ice packaging area.
Salad Dressing Recalled Due to Undeclared Allergens
Undeclared Eggs Found in Salad Dressings During FDA Inspection
On April 3, 2002, FDA’s Seattle District Office conducted an inspection of Chiz's Cougar Cave, St. Anthony, Idaho, a wholesale manufacturer of various salad dressings. The inspection disclosed that allergens were in the product but were not declared on the labeling. Labeling for three different dressings, Ranch, Bleu Cheese, and Veggie Dip, did not include egg as a sub-ingredient of mayonnaise. The firm initiated a voluntary recall of the mislabeled dressings in all size containers manufactured since April 1, 2002. Distribution was limited to retail markets in Idaho state. Corrected labeling was applied to all recalled containers and will be applied to future production at the firm. The recall number for this Class II recall is F-422-424-2.
Allergy Alert for Undeclared Whey Powder
Firm Initiates Class I Recall After FDA Inspection Finds Undeclared Whey in Drink
On August 5, 2002, Gustafson’s Dairy, Inc., Green Cove Springs, Florida, issued an Allergy Alert due to undeclared whey powder in Gustafson Brand Chocolate Break. An FDA inspection of the firm on August 5, 2002, revealed that the firm had manufactured a chocolate drink in one gallon jugs which contained whey powder, an allergen component. However, the whey powder was not declared on the label. The firm recalled all gallons of Chocolate Break drink.
People who have an allergy to whey powder run the risk of a serious or life-threatening allergic reaction if they consume this product. Gustafson's brand gallons of Chocolate Break drink were distributed in North and Central Florida through retail stores. The product was contained in one gallon plastic jugs. All product with a "sell by" date through AUG 26 02D and earlier were included in the recall.
Milk With Eggnog Recalled
Faulty Valve Causes Egg Nog to Leak Into Milk
On November 29, 2001, an FDA investigator from the New England District Office visited Guida-Seibert Dairy Company, New Britain, Connecticut, to obtain recall information. The firm was recalling one Percent Low Fat Milk, packaged in one gallon plastic and half pint wax paper containers due to undeclared egg yolks. The firm initiated telephone calls to customers and schools between November 27 and 29, 2001.
The firm had drivers remove and return product to the firm. In addition, a recall letter was issued and a response reply requested. A Press Release issued on November 27, 2001. The State of Connecticut, Department of Agriculture, and Consumer Protection conducted the follow up and collected a sample. The sample was collected from a consumer. The complainant reported no allergic reaction. A visual examination showed the product to contain nutmeg as an ingredient of Egg Nog. The manufacturer reported that a faulty valve in the processing manifold caused a leak of Egg Nog into the holding tank of the one Percent Lowfat Milk. The recall number for this Class I recall is F-326-2.
FDA In Conjunction With Customs Seize Cheese
From April 2 - 5, 2002, FDA’s Atlanta District Import Operations, in conjunction with U.S. Custom Service, seized and detained 11,214 pounds of cheese from El Salvador at Hartsfield International Airport in Atlanta, Georgia. The cheese, valued at over $35,000.00, was brought in as personal baggage by various passengers for sale on the retail market in various cities in the U.S.